Migraine, Migraine Disorders
Conditions
Keywords
migraine, prophylaxis, prevention
Brief summary
Purpose of the study is to evaluate dose response relationship, efficacy, safety and tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment of migraine headache. Once subjects complete the baseline and meet the randomization criteria, they will complete a 5-wk flexible titration period and then enter the 12 week maintenance period.
Detailed description
MPX111381 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, flexible-dose evaluation of GSK1838262 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day compared with placebo in the prophylactic treatment of migraine headache. Subjects 18 years of age must have experienced at least three migraine headache attacks (with or without aura according to 2004 International Headache Society \[IHS\] criteria 1.1 and 1.2.1) per month during the 3 months prior to screening and at least four migraine headache days but less than 15 total headache days (migraine or non-migraine) per month during the 3 months prior to screening and must maintain this requirement throughout the last 4 weeks of the baseline period. Approximately 528 subjects from approximately 53 centers in North America will be randomized in a 2:1:2:2:1 ratio to the following treatment groups: placebo, GSK1838262 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day. Investigational product will be administered twice daily (morning and evening) with food (e.g., meal or snack). The study will consist of six study periods for a total study duration of up to 30 weeks: Screening (2 weeks), baseline (including randomization, 6 weeks), flexible titration (5 weeks), maintenance (12 weeks), taper (3 weeks) and post-treatment (2 weeks). The flexible titration administration of investigational product is designed to allow subjects to reach the target dose for maintenance treatment or, if unable to reach this target dose, to achieve a maximum tolerated dose for maintenance treatment. Subjects will have the opportunity to undergo a single dose (600 mg/day) downward adjustment during the flexible titration period if intolerability at the current dose occurs. Subsequently, if a single dose downward adjustment has occurred, no further dose adjustments in the study (upward or downward) will be permitted.
Interventions
DRUGGSK1838262
Flexible dosing: 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day
DRUGPlacebo
Placebo-control
Sponsors
GlaxoSmithKline
XenoPort, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient subjects aged 18 years or older. * Females of non-childbearing potential. If of child-bearing potential, is not lactating and has a negative pregnancy test 7 days prior to study treatment initiation and agrees to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy. * Subjects suffering from migraine headache with or without aura, according to 2004 IHS criteria 1.1 and 1.2.1. * Subject has had a history of migraine headache for at least one year, and the age of onset was prior to 50 years. * Subject has consistent migraine headache over time (i.e., incidence and severity). * Subject has had at least three migraine headache attacks per month during the 3 months prior to screening and maintains this requirement during the last 4 weeks of the baseline period * Subject has had at least four migraine headache days but less than 15 total headache days (migraine or non-migraine) per month during the 3 months prior to screening and maintains this requirement during the last 4 weeks of the baseline period. * Subject is able to distinguish migraine headache attacks as discrete from other headaches (i.e., tension-type headaches). * Subject has the ability to read, comprehend and legibly and reliably record information in paper and electronic format as required by the protocol. * Subject must be able to provide written informed consent prior to participation in the study. The contents and process of obtaining informed consent will be in accordance with all applicable regulatory requirements.
Exclusion criteria
* Subject has a history of ergotamine, triptan, opioid, and/or combination pain medication use on \>/=10 days per month on a regular basis for \>/= 3 months. * Subject has failed more than 2 adequate treatments of migraine prophylaxis -where failure is defined as a lack of efficacy with treatment duration of at least 8 weeks. * Subject has history of simple analgesic use on \>/=15 days per month for \>/=3months. * Subject is unable to discontinue prohibited medications during the 2-week screening period and throughout the duration of the study including beta-blockers, benzodiazepines, tricyclic antidepressants, calcium channel blockers, antiepileptic drugs, bupropion or serotonergic noradrenergic reuptake inhibitors (SNRIs). * Subjects who have taken gabapentin or pregabalin previously for the prophylactic treatment of migraine headache. Subjects who have taken gabapentin or pregabalin for treatment of conditions other than migraine are eligible provided, (1) their total exposure to gabapentin and pregabalin is less than 3 months during the preceding 12 months, and (2) the subject stopped taking gabapentin or pregabalin for at least 3 months prior to baseline. * Subject has a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches. * Subject has a current or past history of seizure disorder. * Subject has any of the following medical conditions, laboratory abnormalities or disorders: * Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2x upper limit of normal (ULN) or alkaline phosphatase or bilirubin \>1.5x ULN * Chronic hepatitis B or C with a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Core Antigen Antibody (Hep C antibody) * Impaired renal function defined as either creatinine clearance \<60 mL/min (estimation of creatinine clearance by Cockroft and Gault Method) or renal dysfunction requiring hemodialysis * Corrected QT (QTc) interval \>/= 450 msec based on the average QTc value of triplicate electrocardiograms (ECGs) obtained by the central ECG reader over a brief recording period * QTc interval \>/= 480 msec for subjects with Bundle Branch Block based on the average QTc value of triplicate ECGs obtained by the central ECG reader over a brief recording period * Uncontrolled hypertension at screen or at time of randomization (sitting systolic blood pressure \[SBP\] \>160 mmHg and/or sitting diastolic blood pressure \[DBP\] \>90 mmHg) * Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GSK1838262, or, in the investigator's judgement: * Is considered to be clinically significant and may pose a safety concern, or, * Could interfere with the accurate assessment of safety or efficacy, or, * Could potentially affect a subject's safety or study outcome. * Subject meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for a major depressive episode or for active significant psychiatric disorders within the past year, including dementia, general anxiety disorder, psychotic disorders or bipolar disorder. * Subjects with a history of depression that is in remission, with or without antidepressant treatment, may participate, unless a stable antidepressant regimen includes a prohibited medication. * Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least 3 months prior to screening. * Subject has a history of clinically significant drug or alcohol abuse as defined by DSM IV TR or is unable to refrain from substance abuse throughout the study. * Subject is currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device. * Subject has participated in a clinical study in which the subject was exposed to an investigational or non investigational drug or device: * Within the preceding month for studies unrelated to the current illness (migraine headaches), or * Within the preceding 3 months for studies related to the current illness (migraine headaches). * Subjects who have taken botulinum toxin type A (Botox) within the past 6 months. * Subject has a history of an allergic reaction, or a medically significant adverse reaction to the investigational product or excipients, which, in the opinion of the investigator, makes a subject unsuitable for participation in the study. * Subject is felt to be at risk of non-compliance (e.g., for taking investigational product or for completing the electronic diary \[e-diary\]), in the investigator's opinion. * Subject is a pregnant or nursing woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary. |
| Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack. |
| Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Baseline to the Last 4 weeks of treatment | A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures. |
| Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17 | Week 17 | The PGIC is a single question measured on the 7-point Likert Scale (1 = very much improved; 2 = much improved; 7 = very much worse). A responder is defined as being very much improved or much improved. |
| Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17 | Week 17 | The CGIC is a single question measured on a 7-point Likert Scale. (1 = very much improved; 2= much improved, and 7 = very much worse) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'. |
| Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. |
| Adjusted Mean Change From Baseline in the Number of Migraine Attacks | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. |
| Mean Change From Baseline in the Number of Migraine Headache Periods (MHP) | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. |
| Change From Baseline in the Mean Migraine Attack Duration | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. |
| Change From Baseline in the Mean Peak Migraine Pain Severity | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. |
| Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary. |
| Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary. |
| Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary. |
| Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Baseline and last 4 weeks of treatment prior to taper (up to Week 17) | The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Week 17 | Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant. |
| Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Week 17 | Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale. |
| Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17 | Week 17 | The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life. |
| Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Baseline and Week 17 | The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status. |
Countries
Canada, United States
Participant flow
Pre-assignment details
There were 3 subjects who were randomized but did not take investigational product, and, therefore, were not included in the Safety, Intent to Treat (ITT), or Per Protocol (PP) population.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Oral GEn (XP13512) placebo on Weeks 1-17 | 128 |
| GEn 1200 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day. | 66 |
| GEn 1800 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day. | 134 |
| GEn 2400 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day. | 133 |
| GEn 3000 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day. | 62 |
| Total | 523 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 4 | 17 | 16 | 13 |
| Overall Study | Investigator Discretion | 0 | 0 | 5 | 1 | 1 |
| Overall Study | Lack of Efficacy | 6 | 1 | 1 | 3 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 | 5 | 5 | 3 |
| Overall Study | Participant Withdrew Consent | 8 | 4 | 14 | 7 | 4 |
| Overall Study | Protocol Violation | 6 | 5 | 4 | 5 | 3 |
Baseline characteristics
| Characteristic | Placebo | GEn 1200 mg | GEn 1800 mg | GEn 2400 mg | GEn 3000 mg | Total |
|---|---|---|---|---|---|---|
| Age Continuous | 41.1 years STANDARD_DEVIATION 11.72 | 39.4 years STANDARD_DEVIATION 9.74 | 37.7 years STANDARD_DEVIATION 11.75 | 39.0 years STANDARD_DEVIATION 12.04 | 39.1 years STANDARD_DEVIATION 11.78 | 39.2 years STANDARD_DEVIATION 11.61 |
| Race/Ethnicity, Customized AA/African Heritage and AI or AN and White | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized AA/African Heritage and White | 0 participants | 0 participants | 2 participants | 1 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized African American/African Heritage (AA) | 11 participants | 8 participants | 15 participants | 11 participants | 6 participants | 51 participants |
| Race/Ethnicity, Customized AI or AN and White | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized American Indian (AI) or Alaska Native (AN) | 2 participants | 1 participants | 3 participants | 1 participants | 0 participants | 7 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 3 participants | 6 participants | 6 participants | 3 participants | 22 participants |
| Race/Ethnicity, Customized Asian and White | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 108 participants | 54 participants | 107 participants | 112 participants | 53 participants | 434 participants |
| Sex: Female, Male Female | 111 Participants | 52 Participants | 115 Participants | 105 Participants | 46 Participants | 429 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 19 Participants | 28 Participants | 16 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 86 / 128 | 44 / 66 | 99 / 134 | 101 / 133 | 47 / 62 |
| serious Total, serious adverse events | 2 / 128 | 0 / 66 | 2 / 134 | 1 / 133 | 4 / 62 |
Outcome results
Primary
Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper
A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: Intent to treat (ITT). There were 3 subjects who were randomized but did not take investigational product, and, therefore were not included in the Safety, ITT, or Per Protocol (PP) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper | -3.8 Migraine Headache Days (MHD) | Standard Error 0.38 |
| Average of GEn 1800/2400 mg | Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper | -3.6 Migraine Headache Days (MHD) | Standard Error 0.26 |
| GEn 1800 mg | Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper | -3.8 Migraine Headache Days (MHD) | Standard Error 0.37 |
| GEn 2400 mg | Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper | -3.3 Migraine Headache Days (MHD) | Standard Error 0.37 |
p-value: 0.57995% CI: [-0.6, 1.1]ANCOVA
Secondary
Adjusted Mean Change From Baseline in the Number of Migraine Attacks
A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in the Number of Migraine Attacks | -2.2 Migraine Attacks | Standard Error 0.15 |
| Average of GEn 1800/2400 mg | Adjusted Mean Change From Baseline in the Number of Migraine Attacks | -2.2 Migraine Attacks | Standard Error 0.22 |
| GEn 1800 mg | Adjusted Mean Change From Baseline in the Number of Migraine Attacks | -2.3 Migraine Attacks | Standard Error 0.16 |
| GEn 2400 mg | Adjusted Mean Change From Baseline in the Number of Migraine Attacks | -2.1 Migraine Attacks | Standard Error 0.15 |
| GEn 3000 mg | Adjusted Mean Change From Baseline in the Number of Migraine Attacks | -2.6 Migraine Attacks | Standard Error 0.22 |
Secondary
Change From Baseline in the Mean Migraine Attack Duration
The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Migraine Attack Duration | -0.97 Hours | Standard Error 3.355 |
| Average of GEn 1800/2400 mg | Change From Baseline in the Mean Migraine Attack Duration | 3.01 Hours | Standard Error 5.72 |
| GEn 1800 mg | Change From Baseline in the Mean Migraine Attack Duration | -2.93 Hours | Standard Error 3.658 |
| GEn 2400 mg | Change From Baseline in the Mean Migraine Attack Duration | 2.59 Hours | Standard Error 5 |
| GEn 3000 mg | Change From Baseline in the Mean Migraine Attack Duration | 9.82 Hours | Standard Error 9.975 |
Secondary
Change From Baseline in the Mean Peak Migraine Pain Severity
Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Peak Migraine Pain Severity | -0.12 Scores on a Scale | Standard Error 0.058 |
| Average of GEn 1800/2400 mg | Change From Baseline in the Mean Peak Migraine Pain Severity | -0.13 Scores on a Scale | Standard Error 0.086 |
| GEn 1800 mg | Change From Baseline in the Mean Peak Migraine Pain Severity | -0.12 Scores on a Scale | Standard Error 0.055 |
| GEn 2400 mg | Change From Baseline in the Mean Peak Migraine Pain Severity | -0.04 Scores on a Scale | Standard Error 0.05 |
| GEn 3000 mg | Change From Baseline in the Mean Peak Migraine Pain Severity | -0.09 Scores on a Scale | Standard Error 0.08 |
Secondary
Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia
The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Aura (n=99, 52, 89, 102, 44) | -7.4 Percentage of MA with migraine symptoms | Standard Error 3.64 |
| Placebo | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Nausea (n=125, 62, 123, 121, 59) | -7.8 Percentage of MA with migraine symptoms | Standard Error 2.73 |
| Placebo | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Photophobia (n=99, 52, 89, 102, 44) | -1.9 Percentage of MA with migraine symptoms | Standard Error 2.82 |
| Placebo | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Vomiting (n=99, 52, 89, 102, 44) | 0 Percentage of MA with migraine symptoms | Standard Error 2.6 |
| Placebo | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Phonophobia (n=99, 52, 89, 102, 44) | -5.4 Percentage of MA with migraine symptoms | Standard Error 3.14 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Aura (n=99, 52, 89, 102, 44) | -3.37 Percentage of MA with migraine symptoms | Standard Error 4.834 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Phonophobia (n=99, 52, 89, 102, 44) | 1.2 Percentage of MA with migraine symptoms | Standard Error 3.05 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Nausea (n=125, 62, 123, 121, 59) | -3.6 Percentage of MA with migraine symptoms | Standard Error 3.92 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Vomiting (n=99, 52, 89, 102, 44) | -0.9 Percentage of MA with migraine symptoms | Standard Error 2.98 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Photophobia (n=99, 52, 89, 102, 44) | -3.5 Percentage of MA with migraine symptoms | Standard Error 4.09 |
| GEn 1800 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Phonophobia (n=99, 52, 89, 102, 44) | -0.7 Percentage of MA with migraine symptoms | Standard Error 3.42 |
| GEn 1800 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Aura (n=99, 52, 89, 102, 44) | -7.43 Percentage of MA with migraine symptoms | Standard Error 3.23 |
| GEn 1800 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Photophobia (n=99, 52, 89, 102, 44) | -2.1 Percentage of MA with migraine symptoms | Standard Error 2.86 |
| GEn 1800 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Nausea (n=125, 62, 123, 121, 59) | -8.4 Percentage of MA with migraine symptoms | Standard Error 3.01 |
| GEn 1800 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Vomiting (n=99, 52, 89, 102, 44) | -0.4 Percentage of MA with migraine symptoms | Standard Error 3.01 |
| GEn 2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Nausea (n=125, 62, 123, 121, 59) | -5.4 Percentage of MA with migraine symptoms | Standard Error 2.5 |
| GEn 2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Phonophobia (n=99, 52, 89, 102, 44) | -7.4 Percentage of MA with migraine symptoms | Standard Error 2.88 |
| GEn 2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Photophobia (n=99, 52, 89, 102, 44) | -5.5 Percentage of MA with migraine symptoms | Standard Error 2.64 |
| GEn 2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Vomiting (n=99, 52, 89, 102, 44) | 3.7 Percentage of MA with migraine symptoms | Standard Error 0.4 |
| GEn 2400 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Aura (n=99, 52, 89, 102, 44) | -0.72 Percentage of MA with migraine symptoms | Standard Error 3.044 |
| GEn 3000 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Phonophobia (n=99, 52, 89, 102, 44) | 3.6 Percentage of MA with migraine symptoms | Standard Error 1.93 |
| GEn 3000 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Aura (n=99, 52, 89, 102, 44) | 1.21 Percentage of MA with migraine symptoms | Standard Error 4.372 |
| GEn 3000 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Nausea (n=125, 62, 123, 121, 59) | 1.4 Percentage of MA with migraine symptoms | Standard Error 3.31 |
| GEn 3000 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Photophobia (n=99, 52, 89, 102, 44) | 0.1 Percentage of MA with migraine symptoms | Standard Error 2.49 |
| GEn 3000 mg | Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia | Vomiting (n=99, 52, 89, 102, 44) | 0.4 Percentage of MA with migraine symptoms | Standard Error 4.83 |
Secondary
Mean Change From Baseline in the Number of MHD in All Study Phases
A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Titration(n=124, 59, 119, 124, 59) | -2.434 Migraine Headache Days (MHD) | Standard Error 0.3621 |
| Placebo | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 2nd 4-Week (n=124, 59, 119, 124, 59) | -3.595 Migraine Headache Days (MHD) | Standard Error 0.3784 |
| Placebo | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 3rd 4-Week (n=124, 59, 119, 124, 59) | -3.865 Migraine Headache Days (MHD) | Standard Error 0.3992 |
| Placebo | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Maint Phase (n=112, 54, 101, 107) | -3.846 Migraine Headache Days (MHD) | Standard Error 0.3589 |
| Placebo | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Treat Phase (n=118, 56, 113, 118, 56) | -3.396 Migraine Headache Days (MHD) | Standard Error 0.3422 |
| Placebo | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 1st 4-Week (n=124, 59, 119,124, 59) | -3.147 Migraine Headache Days (MHD) | Standard Error 0.4043 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Treat Phase (n=118, 56, 113, 118, 56) | -2.834 Migraine Headache Days (MHD) | Standard Error 0.564 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 1st 4-Week (n=124, 59, 119,124, 59) | -2.191 Migraine Headache Days (MHD) | Standard Error 0.6758 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Titration(n=124, 59, 119, 124, 59) | -1.920 Migraine Headache Days (MHD) | Standard Error 0.5224 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 3rd 4-Week (n=124, 59, 119, 124, 59) | -3.171 Migraine Headache Days (MHD) | Standard Error 0.666 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Maint Phase (n=112, 54, 101, 107) | -2.854 Migraine Headache Days (MHD) | Standard Error 0.6565 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 2nd 4-Week (n=124, 59, 119, 124, 59) | -2.739 Migraine Headache Days (MHD) | Standard Error 0.6897 |
| GEn 1800 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Maint Phase (n=112, 54, 101, 107) | -4.047 Migraine Headache Days (MHD) | Standard Error 0.3368 |
| GEn 1800 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Treat Phase (n=118, 56, 113, 118, 56) | -3.579 Migraine Headache Days (MHD) | Standard Error 0.314 |
| GEn 1800 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Titration(n=124, 59, 119, 124, 59) | -2.431 Migraine Headache Days (MHD) | Standard Error 0.3375 |
| GEn 1800 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 3rd 4-Week (n=124, 59, 119, 124, 59) | -3.9888 Migraine Headache Days (MHD) | Standard Error 0.381 |
| GEn 1800 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 2nd 4-Week (n=124, 59, 119, 124, 59) | -3.953 Migraine Headache Days (MHD) | Standard Error 0.3794 |
| GEn 1800 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 1st 4-Week (n=124, 59, 119,124, 59) | -3.424 Migraine Headache Days (MHD) | Standard Error 0.3204 |
| GEn 2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Maint Phase (n=112, 54, 101, 107) | -3.794 Migraine Headache Days (MHD) | Standard Error 0.3761 |
| GEn 2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 2nd 4-Week (n=124, 59, 119, 124, 59) | -3.360 Migraine Headache Days (MHD) | Standard Error 0.4201 |
| GEn 2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 3rd 4-Week (n=124, 59, 119, 124, 59) | -3.439 Migraine Headache Days (MHD) | Standard Error 0.4483 |
| GEn 2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 1st 4-Week (n=124, 59, 119,124, 59) | -3.419 Migraine Headache Days (MHD) | Standard Error 0.3941 |
| GEn 2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Treat Phase (n=118, 56, 113, 118, 56) | -3.393 Migraine Headache Days (MHD) | Standard Error 0.3388 |
| GEn 2400 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Titration(n=124, 59, 119, 124, 59) | -2.573 Migraine Headache Days (MHD) | Standard Error 0.3352 |
| GEn 3000 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Treat Phase (n=118, 56, 113, 118, 56) | -3.193 Migraine Headache Days (MHD) | Standard Error 0.5165 |
| GEn 3000 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 3rd 4-Week (n=124, 59, 119, 124, 59) | -3.220 Migraine Headache Days (MHD) | Standard Error 0.6594 |
| GEn 3000 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 2nd 4-Week (n=124, 59, 119, 124, 59) | -3.520 Migraine Headache Days (MHD) | Standard Error 0.5669 |
| GEn 3000 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to 1st 4-Week (n=124, 59, 119,124, 59) | -2.974 Migraine Headache Days (MHD) | Standard Error 0.5522 |
| GEn 3000 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Maint Phase (n=112, 54, 101, 107) | -3.723 Migraine Headache Days (MHD) | Standard Error 0.6492 |
| GEn 3000 mg | Mean Change From Baseline in the Number of MHD in All Study Phases | Baseline to Titration(n=124, 59, 119, 124, 59) | -2.325 Migraine Headache Days (MHD) | Standard Error 0.5055 |
Secondary
Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)
A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Number of Migraine Headache Periods (MHP) | -3.3 Migraine Headache Periods (MHP) | Standard Error 0.35 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Number of Migraine Headache Periods (MHP) | -3.0 Migraine Headache Periods (MHP) | Standard Error 0.5 |
| GEn 1800 mg | Mean Change From Baseline in the Number of Migraine Headache Periods (MHP) | -3.6 Migraine Headache Periods (MHP) | Standard Error 0.36 |
| GEn 2400 mg | Mean Change From Baseline in the Number of Migraine Headache Periods (MHP) | -3.0 Migraine Headache Periods (MHP) | Standard Error 0.34 |
| GEn 3000 mg | Mean Change From Baseline in the Number of Migraine Headache Periods (MHP) | -3.2 Migraine Headache Periods (MHP) | Standard Error 0.5 |
Secondary
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered
The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered | -4.5 Acute Medication Doses Admin. | Standard Error 0.69 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered | -4.8 Acute Medication Doses Admin. | Standard Error 0.97 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered | -5.8 Acute Medication Doses Admin. | Standard Error 0.7 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered | -5.1 Acute Medication Doses Admin. | Standard Error 0.67 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered | -4.5 Acute Medication Doses Admin. | Standard Error 0.69 |
Secondary
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use
The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Opioid Use (n=20, 7, 14, 26, 10) | -1.7 Days | Standard Error 1.66 |
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Non-Opioid Use (n=100, 52, 100, 97, 48) | -5.1 Days | Standard Error 0.75 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Opioid Use (n=20, 7, 14, 26, 10) | 1.4 Days | Standard Error 2.81 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Non-Opioid Use (n=100, 52, 100, 97, 48) | -5.7 Days | Standard Error 0.75 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Opioid Use (n=20, 7, 14, 26, 10) | -3.2 Days | Standard Error 1.97 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Non-Opioid Use (n=100, 52, 100, 97, 48) | -6.2 Days | Standard Error 0.74 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Non-Opioid Use (n=100, 52, 100, 97, 48) | -4.9 Days | Standard Error 0.75 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Opioid Use (n=20, 7, 14, 26, 10) | -6.0 Days | Standard Error 1.45 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Opioid Use (n=20, 7, 14, 26, 10) | -5.1 Days | Standard Error 2.34 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use | Non-Opioid Use (n=100, 52, 100, 97, 48) | -4.4 Days | Standard Error 1.08 |
Secondary
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use
The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses Prescription HA meds (n=89, 38, 80, 88, 39) | -3.6 Acute Migraine Medication Doses | Standard Error 0.78 |
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses OTC HA meds only (n=31, 21, 34, 35, 19) | -6.9 Acute Migraine Medication Doses | Standard Error 1.31 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses Prescription HA meds (n=89, 38, 80, 88, 39) | -3.5 Acute Migraine Medication Doses | Standard Error 1.19 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses OTC HA meds only (n=31, 21, 34, 35, 19) | -7.2 Acute Migraine Medication Doses | Standard Error 1.59 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses Prescription HA meds (n=89, 38, 80, 88, 39) | -4.9 Acute Migraine Medication Doses | Standard Error 0.82 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses OTC HA meds only (n=31, 21, 34, 35, 19) | -7.8 Acute Migraine Medication Doses | Standard Error 1.25 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses OTC HA meds only (n=31, 21, 34, 35, 19) | -7.9 Acute Migraine Medication Doses | Standard Error 1.23 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses Prescription HA meds (n=89, 38, 80, 88, 39) | -4.0 Acute Migraine Medication Doses | Standard Error 0.78 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses Prescription HA meds (n=89, 38, 80, 88, 39) | -3.3 Acute Migraine Medication Doses | Standard Error 1.18 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use | Uses OTC HA meds only (n=31, 21, 34, 35, 19) | -6.9 Acute Migraine Medication Doses | Standard Error 1.68 |
Secondary
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use
The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Triptan Use (n= 72, 30, 65, 63, 32) | -3.3 Acute Migraine Medication Dose | Standard Error 0.88 |
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Not a Triptan User (n = 48, 29, 49, 60, 26) | -6.3 Acute Migraine Medication Dose | Standard Error 1.06 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Triptan Use (n= 72, 30, 65, 63, 32) | -2.9 Acute Migraine Medication Dose | Standard Error 1.35 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Not a Triptan User (n = 48, 29, 49, 60, 26) | -6.7 Acute Migraine Medication Dose | Standard Error 1.36 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Triptan Use (n= 72, 30, 65, 63, 32) | -4.9 Acute Migraine Medication Dose | Standard Error 0.91 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Not a Triptan User (n = 48, 29, 49, 60, 26) | -6.9 Acute Migraine Medication Dose | Standard Error 1.05 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Not a Triptan User (n = 48, 29, 49, 60, 26) | -6.0 Acute Migraine Medication Dose | Standard Error 0.95 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Triptan Use (n= 72, 30, 65, 63, 32) | -4.3 Acute Migraine Medication Dose | Standard Error 0.93 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Triptan Use (n= 72, 30, 65, 63, 32) | -2.6 Acute Migraine Medication Dose | Standard Error 1.31 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use | Not a Triptan User (n = 48, 29, 49, 60, 26) | -6.8 Acute Migraine Medication Dose | Standard Error 1.44 |
Secondary
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use
The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use | -2.0 Days | Standard Error 0.28 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use | -2.3 Days | Standard Error 0.39 |
| GEn 1800 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use | -2.7 Days | Standard Error 0.28 |
| GEn 2400 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use | -2.2 Days | Standard Error 0.27 |
| GEn 3000 mg | Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use | -2.1 Days | Standard Error 0.4 |
Secondary
Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17
The PGIC is a single question measured on the 7-point Likert Scale (1 = very much improved; 2 = much improved; 7 = very much worse). A responder is defined as being very much improved or much improved.
Time frame: Week 17
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17 | 71 participants |
| Average of GEn 1800/2400 mg | Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17 | 40 participants |
| GEn 1800 mg | Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17 | 84 participants |
| GEn 2400 mg | Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17 | 81 participants |
| GEn 3000 mg | Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17 | 36 participants |
Secondary
Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17
The CGIC is a single question measured on a 7-point Likert Scale. (1 = very much improved; 2= much improved, and 7 = very much worse) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'.
Time frame: Week 17
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17 | 75 Participants |
| Average of GEn 1800/2400 mg | Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17 | 40 Participants |
| GEn 1800 mg | Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17 | 84 Participants |
| GEn 2400 mg | Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17 | 85 Participants |
| GEn 3000 mg | Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17 | 32 Participants |
Secondary
Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods
A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.
Time frame: Baseline to the Last 4 weeks of treatment
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache days (n=65, 26, 68, 67, 38) | 54 percentage of participants |
| Placebo | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache periods (n=65, 27, 70, 69, 40) | 54 percentage of participants |
| Placebo | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine attacks (n=64, 31, 67, 67, 39) | 53 percentage of participants |
| Average of GEn 1800/2400 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine attacks (n=64, 31, 67, 67, 39) | 53 percentage of participants |
| Average of GEn 1800/2400 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache days (n=65, 26, 68, 67, 38) | 44 percentage of participants |
| Average of GEn 1800/2400 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache periods (n=65, 27, 70, 69, 40) | 46 percentage of participants |
| GEn 1800 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine attacks (n=64, 31, 67, 67, 39) | 59 percentage of participants |
| GEn 1800 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache days (n=65, 26, 68, 67, 38) | 60 percentage of participants |
| GEn 1800 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache periods (n=65, 27, 70, 69, 40) | 61 percentage of participants |
| GEn 2400 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache days (n=65, 26, 68, 67, 38) | 54 percentage of participants |
| GEn 2400 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache periods (n=65, 27, 70, 69, 40) | 56 percentage of participants |
| GEn 2400 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine attacks (n=64, 31, 67, 67, 39) | 54 percentage of participants |
| GEn 3000 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine attacks (n=64, 31, 67, 67, 39) | 67 percentage of participants |
| GEn 3000 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache days (n=65, 26, 68, 67, 38) | 66 percentage of participants |
| GEn 3000 mg | Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods | Migraine headache periods (n=65, 27, 70, 69, 40) | 69 percentage of participants |
Other Pre-specified
Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17
Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale.
Time frame: Week 17
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | How Effective Overall | 74 Percentage of Patients |
| Placebo | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Overall Satisfaction with Medication | 76 Percentage of Patients |
| Placebo | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Side Effects of the Medication | 79 Percentage of Patients |
| Average of GEn 1800/2400 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Side Effects of the Medication | 32 Percentage of Patients |
| Average of GEn 1800/2400 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | How Effective Overall | 39 Percentage of Patients |
| Average of GEn 1800/2400 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Overall Satisfaction with Medication | 39 Percentage of Patients |
| GEn 1800 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Side Effects of the Medication | 72 Percentage of Patients |
| GEn 1800 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | How Effective Overall | 84 Percentage of Patients |
| GEn 1800 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Overall Satisfaction with Medication | 84 Percentage of Patients |
| GEn 2400 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | How Effective Overall | 81 Percentage of Patients |
| GEn 2400 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Overall Satisfaction with Medication | 84 Percentage of Patients |
| GEn 2400 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Side Effects of the Medication | 75 Percentage of Patients |
| GEn 3000 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Side Effects of the Medication | 28 Percentage of Patients |
| GEn 3000 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | How Effective Overall | 36 Percentage of Patients |
| GEn 3000 mg | Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17 | Overall Satisfaction with Medication | 34 Percentage of Patients |
Other Pre-specified
Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17
The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.
Time frame: Baseline and Week 17
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Restrictive | 30.7 units on a scale | Standard Error 2.31 |
| Placebo | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Emotional Function | 29.7 units on a scale | Standard Error 2.56 |
| Placebo | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Preventive | 22.7 units on a scale | Standard Error 1.98 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Preventive | 28.6 units on a scale | Standard Error 2.67 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Restrictive | 38.7 units on a scale | Standard Error 3.12 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Emotional Function | 37.0 units on a scale | Standard Error 3.46 |
| GEn 1800 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Preventive | 28.0 units on a scale | Standard Error 2.04 |
| GEn 1800 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Restrictive | 37.1 units on a scale | Standard Error 2.38 |
| GEn 1800 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Emotional Function | 34.8 units on a scale | Standard Error 2.64 |
| GEn 2400 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Restrictive | 32.8 units on a scale | Standard Error 2.28 |
| GEn 2400 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Emotional Function | 30.4 units on a scale | Standard Error 2.54 |
| GEn 2400 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Preventive | 23.9 units on a scale | Standard Error 1.96 |
| GEn 3000 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Preventive | 22.4 units on a scale | Standard Error 3.2 |
| GEn 3000 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Role Function Restrictive | 30.9 units on a scale | Standard Error 3.73 |
| GEn 3000 mg | Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17 | Emotional Function | 25.7 units on a scale | Standard Error 4.14 |
Other Pre-specified
Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)
Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.
Time frame: Week 17
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Activity Time (n=99,52, 89, 102, 44) | 0.1 Hours | Standard Error 0.74 |
| Placebo | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Work Time (n=52, 23, 41, 35, 17) | -0.8 Hours | Standard Error 0.49 |
| Placebo | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Time Equivalents (n=99, 52, 89, 102, 44) | -0.2 Hours | Standard Error 0.83 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Activity Time (n=99,52, 89, 102, 44) | -0.1 Hours | Standard Error 1.02 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Work Time (n=52, 23, 41, 35, 17) | -0.3 Hours | Standard Error 0.73 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Time Equivalents (n=99, 52, 89, 102, 44) | -0.5 Hours | Standard Error 1.14 |
| GEn 1800 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Time Equivalents (n=99, 52, 89, 102, 44) | -1.7 Hours | Standard Error 0.87 |
| GEn 1800 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Work Time (n=52, 23, 41, 35, 17) | -0.9 Hours | Standard Error 0.55 |
| GEn 1800 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Activity Time (n=99,52, 89, 102, 44) | -1.2 Hours | Standard Error 0.78 |
| GEn 2400 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Activity Time (n=99,52, 89, 102, 44) | -1.0 Hours | Standard Error 0.73 |
| GEn 2400 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Work Time (n=52, 23, 41, 35, 17) | -0.1 Hours | Standard Error 0.59 |
| GEn 2400 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Time Equivalents (n=99, 52, 89, 102, 44) | -1.1 Hours | Standard Error 0.082 |
| GEn 3000 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Activity Time (n=99,52, 89, 102, 44) | 1.7 Hours | Standard Error 1.11 |
| GEn 3000 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Work Time (n=52, 23, 41, 35, 17) | 0.8 Hours | Standard Error 0.85 |
| GEn 3000 mg | Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities) | Lost Time Equivalents (n=99, 52, 89, 102, 44) | 2.1 Hours | Standard Error 1.24 |
Other Pre-specified
Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17
The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.
Time frame: Week 17
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17 | -10.0 Points on a scale | Standard Error 0.95 |
| Average of GEn 1800/2400 mg | Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17 | -12.2 Points on a scale | Standard Error 1.28 |
| GEn 1800 mg | Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17 | -11.8 Points on a scale | Standard Error 0.98 |
| GEn 2400 mg | Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17 | -9.8 Points on a scale | Standard Error 0.94 |
| GEn 3000 mg | Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17 | -10.3 Points on a scale | Standard Error 1.53 |