Episodic Migraine
Conditions
Keywords
Episodic Migraine, Migraine, Headache
Brief summary
The purpose of this study is to evaluate the efficacy and effectiveness of daily dextromethorphan/quinidine (Nuedexta) in reducing the frequency and progression of episodic migraine.
Detailed description
This is a double-blind, placebo-controlled, randomized, multi-center study to be conducted at the Headache Care Center in Springfield, MO and two other clinics in the United States. Approximately 45 subjects, 18 to 65 years of age, with frequent episodic migraine (6-14 days per month), with (1.2) or without aura (1.1) as defined by ICHD-3beta, will enter a 1-month baseline period to confirm the migraine diagnosis, as well as establish baseline characteristics. At Visit 1, subjects must not have a history of utilization of acute treatment greater than 14 days per month in the preceding 3 month period. Subjects must have a current history of ICHD-3beta migraine with 6-14 migraine days per month in the 3 months prior to the study enrollment. Eligible subjects will be randomly assigned to one of two groups in a 1:1 ratio. Randomization will occur using a computer-generated allocation schedule. Subjects meeting entrance criteria as determined both at screening and through the review of the baseline headache diary will be given the lowest available allocation number for that site. Migraine preventative use is permitted if the subject has been on a stable does for at least 2 months prior to screening and has not failed more than 3 migraine preventatives due to lack of efficacy. The study will consist of 5 office visits per subject: Visit 1 - screening, Visit 2 - randomization, and Visits 3 to 5 - three-month treatment period. During the baseline period, the subject will treat migraines with their current preferred acute treatment of choice.
Interventions
DRUGDextromethorphan and quinidine
DRUGPlacebo
Sponsors
Avanir Pharmaceuticals
Cady, Roger, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* male or female, in otherwise good health, 18 to 65 years of age. * history of frequent episodic migraine for at least 3 months as defined by 6-14 migraine days per month with or without aura according to the ICHD-3beta or a migraine treated with an ergot or triptan which resulted in relief. * onset of migraine before age 50. * stable history of headache at least 3 months prior to screening. * if using daily migraine preventive medications for migraine or for other medical conditions (e.g. propranolol being used for hypertension) and has been on a stable dose and regimen for at least 2 months prior to beginning the baseline period. * female, of childbearing potential, and agrees to maintain true abstinence or use (or have their partner use) one of the listed methods of birth control for the duration of the study: hormonal contraceptive, intrauterine device (IUD), condoms, diaphragm, and/or vasectomy. The use of barrier contraceptive (condom or diaphragm) should always be supplemented with the use of a spermicide. Note: To be considered not of childbearing potential, subject must be 6 weeks post-surgical bilateral oophorectomy, hysterectomy, or bilateral tubal ligation, or postmenopausal for at least one year.
Exclusion criteria
* unable to understand the study requirements, the informed consent, or complete headache records as required per protocol. * pregnant, actively trying to become pregnant, or breast-feeding. * female of childbearing potential not using adequate contraceptive measures. * experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine. * history of Medication Overuse Headache (Appendix II) in the 3 months prior to study enrollment or during the baseline phase. * history of acute migraine treatment greater than 14 days per month in 3 months prior to screening. * history of 3 or more failed preventative medications due to lack of efficacy for prophylactic treatment of migraine after an adequate therapeutic trial. * received onabotulinumtoxinA injections within 3 months prior to screening and/or will receive onabotulinumtoxinA injections during the study. * abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 1 year: opioids, alcohol, barbiturates, benzodiazepine, cocaine. * taken, or plans to take: a monoamine oxidase inhibitor (MAOI) including herbal preparations containing St. John's wort (Hypericum perforatum) within 14 days of Visit 1, concomitant medications and/or foods containing dextromethorphan, quinidine, quinine, mefloquine, paxil, dicyclomine, digitalis, thioridazine or pimozide (medications that prolong QT interval) anytime within the 2 weeks prior to screening through 2 weeks post final study treatment. * history of hypersensitivity to medications containing dextromethorphan. * history of hypersensitivity to medications or foods containing quinidine. * at an increased risk of developing serotonin syndrome, in the opinion of the investigator. * history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study. * unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure. * cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's angina); has symptoms of ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome. * ECG results outside normal limits (\> 470 msec), prolonged QT interval, congenital long QT syndrome, torsades de pointes, or complete AV block. * has uncontrolled hypertension (≥ 140/90mmHg in either the systolic or diastolic measurements in 2 out of 3 BP readings at screening). * serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events, in the opinion of the investigator. * any psychiatric disorder with psychotic features and any other psychiatric disorder not stable or well controlled, that would interfere in their ability to complete study activities. * received any investigational agents within 30 days prior to Visit 1. * plans to participate in another clinical study at any time during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Days in Each Treatment Period Month | Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116) | The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Days in Each Treatment Period Month | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) | The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. |
| Headache Severity in Each Treatment Period Month | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) | The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain. |
| Headache Duration in Each Treatment Period Month | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) | The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours. |
| 50% Headache Reduction | Baseline (Day 0) to Treatment Period Month 3 (Day 116) | The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm. |
| Headache Days in Treatment Period Month 3 | End of Treatment Period Month 3 (Day 116) | The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period. |
| Migraine Disability Assessment Scale (MIDAS) | Visit 2 (Day 28) to Visit 5 (Day 116) | MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) how many days in the last 3 months... questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following: 0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability |
| Headache Health Score | Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) | Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life. |
| Adverse Events | Baseline (Day 0) to Treatment Period Month 3 (Day 116) | Compare the number of adverse events in the Nuedexta arm vs. the placebo arm. |
| Acute Medication Use in Each Treatment Period Month | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) | The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm |
Countries
United States
Participant flow
Pre-assignment details
A total of 90 participants were screened, 14 failed to meet the inclusion criteria and were screen failed. 76 participants were enrolled into a 28-day run-in period. 31 were excluded from the study prior to being assigned to a treatment arm, due to failure to meet inclusion criteria. A total of 45 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Nuedexta One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine | 22 |
| Placebo One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo | 23 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | Nuedexta |
|---|---|---|---|
| Acute Medication Use | 15.0 Number of medications STANDARD_DEVIATION 8.68 | 13.4 Number of medications STANDARD_DEVIATION 7.44 | 16.4 Number of medications STANDARD_DEVIATION 9.58 |
| Age, Continuous | 44.69 years STANDARD_DEVIATION 10.58 | 44.17 years STANDARD_DEVIATION 11.62 | 45.23 years STANDARD_DEVIATION 9.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 23 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Headache Days | 10.4 Number of Headache Days STANDARD_DEVIATION 3.96 | 10.29 Number of Headache Days STANDARD_DEVIATION 5.28 | 10.5 Number of Headache Days STANDARD_DEVIATION 2.5 |
| Headache Duration | 5.86 Hours STANDARD_DEVIATION 2.07 | 5.54 Hours STANDARD_DEVIATION 2.03 | 6.14 Hours STANDARD_DEVIATION 2.12 |
| Headache Severity | 2.09 units on a scale STANDARD_DEVIATION 0.362 | 2.17 units on a scale STANDARD_DEVIATION 0.326 | 2.02 units on a scale STANDARD_DEVIATION 0.386 |
| Migraine Days | 8.54 Number of Migraine days STANDARD_DEVIATION 2.34 | 8 Number of Migraine days STANDARD_DEVIATION 2.5 | 9 Number of Migraine days STANDARD_DEVIATION 2.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 21 Participants | 21 Participants |
| Region of Enrollment United States | 45 participants | 23 participants | 22 participants |
| Sex: Female, Male Female | 40 Participants | 19 Participants | 21 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 4 / 22 | 9 / 23 |
| serious Total, serious adverse events | 0 / 22 | 1 / 23 |
Outcome results
Primary
Headache Days in Each Treatment Period Month
The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.
Time frame: Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuedexta | Headache Days in Each Treatment Period Month | Treatment Month 1 | 7.1 Number of Headache days | Standard Deviation 3.31 |
| Nuedexta | Headache Days in Each Treatment Period Month | Treatment Month 2 | 7.05 Number of Headache days | Standard Deviation 3.82 |
| Nuedexta | Headache Days in Each Treatment Period Month | Treatment Month 3 | 7.10 Number of Headache days | Standard Deviation 3.8 |
| Placebo | Headache Days in Each Treatment Period Month | Treatment Month 1 | 10.88 Number of Headache days | Standard Deviation 6.25 |
| Placebo | Headache Days in Each Treatment Period Month | Treatment Month 2 | 9.47 Number of Headache days | Standard Deviation 6.15 |
| Placebo | Headache Days in Each Treatment Period Month | Treatment Month 3 | 9.77 Number of Headache days | Standard Deviation 7.09 |
Secondary
50% Headache Reduction
The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm.
Time frame: Baseline (Day 0) to Treatment Period Month 3 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nuedexta | 50% Headache Reduction | Treatment Month 1 | 6 Participants |
| Nuedexta | 50% Headache Reduction | Treatment Month 2 | 7 Participants |
| Nuedexta | 50% Headache Reduction | Treatment Month 3 | 8 Participants |
| Placebo | 50% Headache Reduction | Treatment Month 1 | 0 Participants |
| Placebo | 50% Headache Reduction | Treatment Month 2 | 2 Participants |
| Placebo | 50% Headache Reduction | Treatment Month 3 | 8 Participants |
Secondary
Acute Medication Use in Each Treatment Period Month
The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm
Time frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuedexta | Acute Medication Use in Each Treatment Period Month | Treatment Month 1 | 9.45 Number of medication doses | Standard Deviation 6.82 |
| Nuedexta | Acute Medication Use in Each Treatment Period Month | Treatment Month 2 | 9.50 Number of medication doses | Standard Deviation 7.08 |
| Nuedexta | Acute Medication Use in Each Treatment Period Month | Treatment Month 3 | 11.55 Number of medication doses | Standard Deviation 11.01 |
| Placebo | Acute Medication Use in Each Treatment Period Month | Treatment Month 1 | 13.06 Number of medication doses | Standard Deviation 12.3 |
| Placebo | Acute Medication Use in Each Treatment Period Month | Treatment Month 2 | 11.41 Number of medication doses | Standard Deviation 12.52 |
| Placebo | Acute Medication Use in Each Treatment Period Month | Treatment Month 3 | 10.94 Number of medication doses | Standard Deviation 12.95 |
Secondary
Adverse Events
Compare the number of adverse events in the Nuedexta arm vs. the placebo arm.
Time frame: Baseline (Day 0) to Treatment Period Month 3 (Day 116)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nuedexta | Adverse Events | 9 Number of Adverse Events |
| Placebo | Adverse Events | 35 Number of Adverse Events |
Secondary
Headache Days in Treatment Period Month 3
The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.
Time frame: End of Treatment Period Month 3 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nuedexta | Headache Days in Treatment Period Month 3 | 7.1 Number of headache days | Standard Deviation 3.8 |
| Placebo | Headache Days in Treatment Period Month 3 | 9.77 Number of headache days | Standard Deviation 7.09 |
Secondary
Headache Duration in Each Treatment Period Month
The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours.
Time frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuedexta | Headache Duration in Each Treatment Period Month | Treatment Month 2 | 6.33 Hours | Standard Deviation 4.06 |
| Nuedexta | Headache Duration in Each Treatment Period Month | Treatment Month 1 | 5.39 Hours | Standard Deviation 2.38 |
| Nuedexta | Headache Duration in Each Treatment Period Month | Treatment Month 3 | 6.60 Hours | Standard Deviation 4.81 |
| Placebo | Headache Duration in Each Treatment Period Month | Treatment Month 1 | 5.30 Hours | Standard Deviation 2.25 |
| Placebo | Headache Duration in Each Treatment Period Month | Treatment Month 2 | 5.75 Hours | Standard Deviation 2.78 |
| Placebo | Headache Duration in Each Treatment Period Month | Treatment Month 3 | 5.46 Hours | Standard Deviation 2.72 |
Secondary
Headache Health Score
Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life.
Time frame: Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuedexta | Headache Health Score | Visit 3 (Day 57) | 87.62 units on a scale | Standard Deviation 6.57 |
| Nuedexta | Headache Health Score | Visit 2 (Day 28) | 78.71 units on a scale | Standard Deviation 5.25 |
| Nuedexta | Headache Health Score | Visit 4 (Day 85) | 87.14 units on a scale | Standard Deviation 8.31 |
| Nuedexta | Headache Health Score | Visit 5 (Day 116) | 87.57 units on a scale | Standard Deviation 6.97 |
| Placebo | Headache Health Score | Visit 5 (Day 116) | 84.10 units on a scale | Standard Deviation 10.76 |
| Placebo | Headache Health Score | Visit 2 (Day 28) | 81.07 units on a scale | Standard Deviation 7.37 |
| Placebo | Headache Health Score | Visit 3 (Day 57) | 80.30 units on a scale | Standard Deviation 10.62 |
| Placebo | Headache Health Score | Visit 4 (Day 85) | 82.28 units on a scale | Standard Deviation 10.77 |
Secondary
Headache Severity in Each Treatment Period Month
The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain.
Time frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuedexta | Headache Severity in Each Treatment Period Month | Treatment Month 1 | 1.69 units on a scale | Standard Deviation 0.37 |
| Nuedexta | Headache Severity in Each Treatment Period Month | Treatment Month 2 | 1.81 units on a scale | Standard Deviation 0.52 |
| Nuedexta | Headache Severity in Each Treatment Period Month | Treatment Month 3 | 1.74 units on a scale | Standard Deviation 0.46 |
| Placebo | Headache Severity in Each Treatment Period Month | Treatment Month 1 | 2.04 units on a scale | Standard Deviation 0.43 |
| Placebo | Headache Severity in Each Treatment Period Month | Treatment Month 2 | 1.96 units on a scale | Standard Deviation 0.45 |
| Placebo | Headache Severity in Each Treatment Period Month | Treatment Month 3 | 1.86 units on a scale | Standard Deviation 0.51 |
Secondary
Migraine Days in Each Treatment Period Month
The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.
Time frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuedexta | Migraine Days in Each Treatment Period Month | Treatment Month 1 | 5.65 Number of Migraine days | Standard Deviation 3.35 |
| Nuedexta | Migraine Days in Each Treatment Period Month | Treatment Month 2 | 5.85 Number of Migraine days | Standard Deviation 3.48 |
| Nuedexta | Migraine Days in Each Treatment Period Month | Treatment Month 3 | 6.05 Number of Migraine days | Standard Deviation 3.63 |
| Placebo | Migraine Days in Each Treatment Period Month | Treatment Month 1 | 7.65 Number of Migraine days | Standard Deviation 2.71 |
| Placebo | Migraine Days in Each Treatment Period Month | Treatment Month 2 | 6.94 Number of Migraine days | Standard Deviation 4.05 |
| Placebo | Migraine Days in Each Treatment Period Month | Treatment Month 3 | 7.29 Number of Migraine days | Standard Deviation 4.3 |
Secondary
Migraine Disability Assessment Scale (MIDAS)
MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) how many days in the last 3 months... questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following: 0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability
Time frame: Visit 2 (Day 28) to Visit 5 (Day 116)
Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuedexta | Migraine Disability Assessment Scale (MIDAS) | Visit 2 (Day28) | 34.95 units on a scale | Standard Deviation 22.65 |
| Nuedexta | Migraine Disability Assessment Scale (MIDAS) | Visit 5 (Day 116) | 22.50 units on a scale | Standard Deviation 17.41 |
| Placebo | Migraine Disability Assessment Scale (MIDAS) | Visit 2 (Day28) | 32.88 units on a scale | Standard Deviation 29.95 |
| Placebo | Migraine Disability Assessment Scale (MIDAS) | Visit 5 (Day 116) | 30.35 units on a scale | Standard Deviation 42.47 |