Migraine Disorders
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.
Interventions
BIOLOGICALALD403 (Eptinezumab)
BIOLOGICALPlacebo
Sponsors
Alder Biopharmaceuticals, 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 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening. * During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days. * Headache eDiary was completed on at least 24 of the 28 days prior to randomization.
Exclusion criteria
* Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome). * Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded. * Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period. * History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine. * Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening. * Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Monthly Migraine Days | Week 1-12 | Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 75% Migraine Responder Rate - 4 Week | Week 1-4 | Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline. |
| 50% Migraine Responder Rate | Week 1-12 | Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline. |
| Percentage of Participants With a Migraine on the Day After Dosing | Day 1 | The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment Day and Day 1 is the day after dosing. |
| Change in Monthly Acute Medication Days | Week 1-12 | An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary. |
| Change From Baseline of Headache Impact Test (HIT-6) Score | Baseline to Week 12 | The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). |
| Change in Migraine Prevalence From Baseline to Week 4 | Baseline to Week 4 | The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4. |
| 75% Headache Responder Rate | Week 1-12 | Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline. |
| 50% Headache Responder Rate | Week 1-12 | Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline. |
| 100% Migraine Responder Rate | Week 1-12 | For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%. |
| 100% Headache Responder Rate | Week 1-12 | For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%. |
| Change From Baseline in Monthly Migraine Days (Weeks 13-24) | Week 13-24 | Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24. |
| Change From Baseline in Monthly Headache Days (Weeks 1-12) | Week 1-12 | Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12. |
| 75% Migraine Responder Rate | Week 1-12 | Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline. |
| Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication | Week 1-12 | The percentage of migraines with acute medication usage. Participants with no migraine will be included with a rate of zero. |
| Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication | Week 1-12 | The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero. |
| Percent Change in Frequency of Migraine Days - Week 1-12 | Week 1-12 | The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12. |
| Percent Change in Frequency of Headache Days - Week 1-12 | Week 1-12 | The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12. |
| Change From Baseline in Percentage of Severe Migraines | Week 1-12 | The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12. |
| Change From Baseline in Percentage of Severe Headache | Week 1-12 | The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12. |
| Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | Week 1-12 | Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks. |
| Change From Baseline in Monthly Headache Hours, Weeks 1-12 | Week 1-12 | Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals. |
| Duration of Migraine-Free Intervals | 32 weeks | The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded. |
| Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Baseline to Week 12 | The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement. |
| Patient Global Impression of Change (PGIC) at Week 12 | Week 12 | The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. |
| Health Related Quality of Life (EQ-5D-5L) at Week 12 | Week 12 | The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. |
| Time to First Migraine After Dosing | 32 weeks | The time to first migraine after dosing based upon the migraine data entered into the eDiary |
Countries
Belgium, Czechia, Denmark, Georgia, Germany, Hungary, Italy, Russia, Slovakia, Spain, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 2263 participants signed the ICF, of which 1121 participants met the entry criteria and were randomized into the trial.
Participants by arm
| Arm | Count |
|---|---|
| 300 mg ALD403 Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | 350 |
| 100 mg ALD403 Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | 356 |
| Placebo Participants were randomized to receive a single placebo IV infusion on Days 0 and 84 (Week 12). | 366 |
| Total | 1,072 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 0 | 1 |
| Overall Study | Lack of Efficacy | 6 | 5 | 10 |
| Overall Study | Lost to Follow-up | 9 | 10 | 17 |
| Overall Study | Other | 14 | 8 | 7 |
| Overall Study | Physician Decision | 0 | 2 | 1 |
| Overall Study | Study Burden | 8 | 7 | 3 |
| Overall Study | Withdrawal by Subject | 9 | 16 | 11 |
Baseline characteristics
| Characteristic | 300 mg ALD403 | 100 mg ALD403 | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 10.36 | 41.0 years STANDARD_DEVIATION 11.72 | 39.6 years STANDARD_DEVIATION 11.28 | 40.5 years STANDARD_DEVIATION 11.15 |
| Baseline Migraine Days Greater than or equal to 17 days per month | 153 Participants | 157 Participants | 160 Participants | 470 Participants |
| Baseline Migraine Days Less than 17 days per month | 197 Participants | 199 Participants | 206 Participants | 602 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 33 Participants | 35 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 332 Participants | 323 Participants | 331 Participants | 986 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 00 Participants | 0 Participants | 0 Participants |
| Medication overuse headache diagnosis No | 203 Participants | 217 Participants | 221 Participants | 641 Participants |
| Medication overuse headache diagnosis Yes | 147 Participants | 139 Participants | 145 Participants | 431 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 21 Participants | 38 Participants | 82 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 322 Participants | 332 Participants | 321 Participants | 975 Participants |
| Region of Enrollment Belgium | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Czechia | 12 participants | 7 participants | 8 participants | 27 participants |
| Region of Enrollment Denmark | 3 participants | 2 participants | 1 participants | 6 participants |
| Region of Enrollment Georgia | 36 participants | 38 participants | 23 participants | 97 participants |
| Region of Enrollment Germany | 3 participants | 2 participants | 5 participants | 10 participants |
| Region of Enrollment Hungary | 3 participants | 5 participants | 3 participants | 11 participants |
| Region of Enrollment Italy | 7 participants | 3 participants | 5 participants | 15 participants |
| Region of Enrollment Russia | 32 participants | 27 participants | 27 participants | 86 participants |
| Region of Enrollment Slovakia | 4 participants | 5 participants | 8 participants | 17 participants |
| Region of Enrollment Spain | 18 participants | 22 participants | 18 participants | 58 participants |
| Region of Enrollment Ukraine | 34 participants | 43 participants | 33 participants | 110 participants |
| Region of Enrollment United Kingdom | 3 participants | 4 participants | 2 participants | 9 participants |
| Region of Enrollment United States | 195 participants | 198 participants | 232 participants | 625 participants |
| Sex: Female, Male Female | 314 Participants | 307 Participants | 325 Participants | 946 Participants |
| Sex: Female, Male Male | 36 Participants | 49 Participants | 41 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 350 | 0 / 356 | 0 / 366 |
| other Total, other adverse events | 52 / 350 | 34 / 356 | 42 / 366 |
| serious Total, serious adverse events | 4 / 350 | 3 / 356 | 3 / 366 |
Outcome results
Primary
Change From Baseline in Monthly Migraine Days
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Migraine Days | -8.2 Migraine Days |
| 100 mg ALD403 | Change From Baseline in Monthly Migraine Days | -7.7 Migraine Days |
| Placebo | Change From Baseline in Monthly Migraine Days | -5.6 Migraine Days |
p-value: <0.000195% CI: [-3.45, -1.74]ANCOVA
p-value: <0.000195% CI: [-2.88, -1.18]ANCOVA
Secondary
100% Headache Responder Rate
For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 300 mg ALD403 | 100% Headache Responder Rate | 3.8 Percent of participants |
| 100 mg ALD403 | 100% Headache Responder Rate | 2.0 Percent of participants |
| Placebo | 100% Headache Responder Rate | 1.5 Percent of participants |
Secondary
100% Migraine Responder Rate
For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 300 mg ALD403 | 100% Migraine Responder Rate | 15.1 percent of participants |
| 100 mg ALD403 | 100% Migraine Responder Rate | 10.8 percent of participants |
| Placebo | 100% Migraine Responder Rate | 5.1 percent of participants |
Secondary
50% Headache Responder Rate
Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 50% Headache Responder Rate | 169 Participants |
| 100 mg ALD403 | 50% Headache Responder Rate | 150 Participants |
| Placebo | 50% Headache Responder Rate | 95 Participants |
Secondary
50% Migraine Responder Rate
Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 50% Migraine Responder Rate | 215 Participants |
| 100 mg ALD403 | 50% Migraine Responder Rate | 205 Participants |
| Placebo | 50% Migraine Responder Rate | 144 Participants |
p-value: <0.000195% CI: [14.9, 29.2]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [11.1, 25.4]Cochran-Mantel-Haenszel
Secondary
75% Headache Responder Rate
Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 75% Headache Responder Rate | 61 Participants |
| 100 mg ALD403 | 75% Headache Responder Rate | 49 Participants |
| Placebo | 75% Headache Responder Rate | 29 Participants |
Secondary
75% Migraine Responder Rate
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 75% Migraine Responder Rate | 116 Participants |
| 100 mg ALD403 | 75% Migraine Responder Rate | 95 Participants |
| Placebo | 75% Migraine Responder Rate | 55 Participants |
p-value: <0.000195% CI: [12, 24.3]Cochran-Mantel-Haenszel
p-value: 0.000195% CI: [5.8, 17.5]Cochran-Mantel-Haenszel
Secondary
75% Migraine Responder Rate - 4 Week
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.
Time frame: Week 1-4
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 75% Migraine Responder Rate - 4 Week | 129 Participants |
| 100 mg ALD403 | 75% Migraine Responder Rate - 4 Week | 110 Participants |
| Placebo | 75% Migraine Responder Rate - 4 Week | 57 Participants |
p-value: <0.000195% CI: [15, 27.6]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [9.3, 21.4]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Monthly Headache Days (Weeks 1-12)
Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Headache Days (Weeks 1-12) | -8.8 Headache Days | Standard Deviation 6.1 |
| 100 mg ALD403 | Change From Baseline in Monthly Headache Days (Weeks 1-12) | -8.2 Headache Days | Standard Deviation 5.78 |
| Placebo | Change From Baseline in Monthly Headache Days (Weeks 1-12) | -6.4 Headache Days | Standard Deviation 5.99 |
Secondary
Change From Baseline in Monthly Headache Hours, Weeks 1-12
Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -82.5 headache hours | Standard Deviation 88.85 |
| 100 mg ALD403 | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -74.6 headache hours | Standard Deviation 84.57 |
| Placebo | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -54.8 headache hours | Standard Deviation 97.15 |
Secondary
Change From Baseline in Monthly Migraine Days (Weeks 13-24)
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.
Time frame: Week 13-24
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Migraine Days (Weeks 13-24) | -9.0 Migraine Days | Standard Deviation 6.72 |
| 100 mg ALD403 | Change From Baseline in Monthly Migraine Days (Weeks 13-24) | -8.3 Migraine Days | Standard Deviation 7.03 |
| Placebo | Change From Baseline in Monthly Migraine Days (Weeks 13-24) | -6.4 Migraine Days | Standard Deviation 7.16 |
Secondary
Change From Baseline in Monthly Migraine Hours, Weeks 1-12
Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -80.9 migraine hours | Standard Deviation 89.17 |
| 100 mg ALD403 | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -75.2 migraine hours | Standard Deviation 90.4 |
| Placebo | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -52.8 migraine hours | Standard Deviation 101.82 |
Secondary
Change From Baseline in Percentage of Severe Headache
The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Percentage of Severe Headache | -14.00 percentage of headaches scored severe | Standard Deviation 22.5 |
| 100 mg ALD403 | Change From Baseline in Percentage of Severe Headache | -14.01 percentage of headaches scored severe | Standard Deviation 20.95 |
| Placebo | Change From Baseline in Percentage of Severe Headache | -9.12 percentage of headaches scored severe | Standard Deviation 22.12 |
Secondary
Change From Baseline in Percentage of Severe Migraines
The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Percentage of Severe Migraines | -18.17 percentage of migraines scored severe | Standard Deviation 27.9 |
| 100 mg ALD403 | Change From Baseline in Percentage of Severe Migraines | -16.39 percentage of migraines scored severe | Standard Deviation 26.17 |
| Placebo | Change From Baseline in Percentage of Severe Migraines | -10.82 percentage of migraines scored severe | Standard Deviation 25.73 |
Secondary
Change From Baseline of Headache Impact Test (HIT-6) Score
The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact).
Time frame: Baseline to Week 12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 300 mg ALD403 | Change From Baseline of Headache Impact Test (HIT-6) Score | -7.3 score on a scale |
| 100 mg ALD403 | Change From Baseline of Headache Impact Test (HIT-6) Score | -6.2 score on a scale |
| Placebo | Change From Baseline of Headache Impact Test (HIT-6) Score | -4.5 score on a scale |
p-value: <0.000195% CI: [-3.91, -1.84]ANCOVA
p-value: 0.00195% CI: [-2.76, -0.7]ANCOVA
Secondary
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.
Time frame: Baseline to Week 12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 300 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Role Physical | 6.0 score on a scale | Standard Deviation 8.46 |
| 300 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | General Health | 3.5 score on a scale | Standard Deviation 7.45 |
| 300 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Physical Functioning | 3.3 score on a scale | Standard Deviation 6.22 |
| 300 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Bodily Pain | 6.2 score on a scale | Standard Deviation 8.71 |
| 300 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Vitality | 4.5 score on a scale | Standard Deviation 9.02 |
| 100 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Bodily Pain | 5.1 score on a scale | Standard Deviation 9.12 |
| 100 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | General Health | 2.3 score on a scale | Standard Deviation 6.89 |
| 100 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Vitality | 4.2 score on a scale | Standard Deviation 8.84 |
| 100 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Role Physical | 4.6 score on a scale | Standard Deviation 8.53 |
| 100 mg ALD403 | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Physical Functioning | 2.6 score on a scale | Standard Deviation 5.98 |
| Placebo | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Vitality | 2.3 score on a scale | Standard Deviation 8.23 |
| Placebo | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Physical Functioning | 1.5 score on a scale | Standard Deviation 6.88 |
| Placebo | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Role Physical | 3.6 score on a scale | Standard Deviation 8.08 |
| Placebo | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Bodily Pain | 4.0 score on a scale | Standard Deviation 8.55 |
| Placebo | Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | General Health | 0.7 score on a scale | Standard Deviation 7.53 |
Secondary
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication | -7.46 percentage of acute medication headaches | Standard Deviation 23.32 |
| 100 mg ALD403 | Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication | -3.08 percentage of acute medication headaches | Standard Deviation 21.31 |
| Placebo | Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication | -0.16 percentage of acute medication headaches | Standard Deviation 19.12 |
Secondary
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
The percentage of migraines with acute medication usage. Participants with no migraine will be included with a rate of zero.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication | -14.10 percentage of acute medication migraines | Standard Deviation 28.86 |
| 100 mg ALD403 | Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication | -9.79 percentage of acute medication migraines | Standard Deviation 26.78 |
| Placebo | Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication | -2.82 percentage of acute medication migraines | Standard Deviation 20.94 |
Secondary
Change in Migraine Prevalence From Baseline to Week 4
The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4.
Time frame: Baseline to Week 4
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 300 mg ALD403 | Change in Migraine Prevalence From Baseline to Week 4 | -29.8 percentage of participants with migraine |
| 100 mg ALD403 | Change in Migraine Prevalence From Baseline to Week 4 | -27.1 percentage of participants with migraine |
| Placebo | Change in Migraine Prevalence From Baseline to Week 4 | -18.8 percentage of participants with migraine |
p-value: <0.000195% CI: [-14.22, -7.77]Repeated Measures Model
p-value: <0.000195% CI: [-11.48, -5.05]Repeated Measures Model
Secondary
Change in Monthly Acute Medication Days
An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change in Monthly Acute Medication Days | -3.5 Acute Medication Migraine Days | Standard Deviation 4.62 |
| 100 mg ALD403 | Change in Monthly Acute Medication Days | -3.3 Acute Medication Migraine Days | Standard Deviation 4.89 |
| Placebo | Change in Monthly Acute Medication Days | -1.9 Acute Medication Migraine Days | Standard Deviation 4.18 |
p-value: <0.000195% CI: [-1.88, -0.87]ANCOVA
p-value: <0.000195% CI: [-1.66, -0.65]ANCOVA
Secondary
Duration of Migraine-Free Intervals
The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded.
Time frame: 32 weeks
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Duration of Migraine-Free Intervals | <= 7 days | 132 Participants |
| 300 mg ALD403 | Duration of Migraine-Free Intervals | 8-14 days | 86 Participants |
| 300 mg ALD403 | Duration of Migraine-Free Intervals | 15-21 days | 38 Participants |
| 300 mg ALD403 | Duration of Migraine-Free Intervals | >21 days | 94 Participants |
| 100 mg ALD403 | Duration of Migraine-Free Intervals | >21 days | 73 Participants |
| 100 mg ALD403 | Duration of Migraine-Free Intervals | <= 7 days | 146 Participants |
| 100 mg ALD403 | Duration of Migraine-Free Intervals | 15-21 days | 42 Participants |
| 100 mg ALD403 | Duration of Migraine-Free Intervals | 8-14 days | 95 Participants |
| Placebo | Duration of Migraine-Free Intervals | >21 days | 42 Participants |
| Placebo | Duration of Migraine-Free Intervals | 8-14 days | 75 Participants |
| Placebo | Duration of Migraine-Free Intervals | 15-21 days | 23 Participants |
| Placebo | Duration of Migraine-Free Intervals | <= 7 days | 226 Participants |
Secondary
Health Related Quality of Life (EQ-5D-5L) at Week 12
The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Time frame: Week 12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | No problems | 320 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | No problems | 122 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Severe Problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Slight Problems | 91 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Extreme Problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Extreme Problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Slight Problems | 41 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Severe Problems | 5 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | No problems | 227 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Severe Problems | 4 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Moderate Problems | 27 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Slight Problems | 79 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | No problems | 220 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Moderate Problems | 8 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Severe Problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Extreme Problems | 2 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Severe Problems | 18 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Extreme Problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Extreme Problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Moderate Problems | 56 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Moderate Problems | 23 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Slight Problems | 140 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Slight Problems | 13 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | No problems | 289 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Moderate Problems | 5 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Extreme Problems | 0 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Slight Problems | 87 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | No problems | 289 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Slight Problems | 41 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Severe Problems | 1 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Extreme Problems | 0 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | No problems | 337 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Slight Problems | 6 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Moderate Problems | 1 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Severe Problems | 0 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Extreme Problems | 0 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | No problems | 233 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Slight Problems | 78 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Moderate Problems | 28 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Severe Problems | 5 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Extreme Problems | 0 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | No problems | 121 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Slight Problems | 127 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Moderate Problems | 78 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Severe Problems | 14 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Extreme Problems | 4 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | No problems | 227 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Moderate Problems | 25 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Severe Problems | 5 Participants |
| 100 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Moderate Problems | 13 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | No problems | 130 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | No problems | 331 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Extreme Problems | 1 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Slight Problems | 120 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Extreme Problems | 0 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Severe Problems | 5 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Moderate Problems | 75 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Severe Problems | 2 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Moderate Problems | 27 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Severe Problems | 16 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Slight Problems | 7 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Extreme Problems | 2 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Slight Problems | 37 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Slight Problems | 71 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | No problems | 241 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Moderate Problems | 6 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Moderate Problems | 26 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Extreme Problems | 0 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | No problems | 219 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Severe Problems | 4 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Severe Problems | 1 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | No problems | 298 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Extreme Problems | 1 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Moderate Problems | 4 Participants |
| Placebo | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Slight Problems | 91 Participants |
Secondary
Patient Global Impression of Change (PGIC) at Week 12
The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Time frame: Week 12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Very Much Improved | 73 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Minimally Worse | 3 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Minimally Improved | 68 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Much Worse | 0 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Very Much Worse | 0 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | No Change | 51 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Much Improved | 142 Participants |
| 100 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | No Change | 69 Participants |
| 100 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Much Worse | 2 Participants |
| 100 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Very Much Improved | 54 Participants |
| 100 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Much Improved | 126 Participants |
| 100 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Minimally Improved | 82 Participants |
| 100 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Minimally Worse | 10 Participants |
| 100 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 12 | Very Much Worse | 1 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 12 | Very Much Worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 12 | Much Improved | 92 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 12 | Minimally Improved | 85 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 12 | No Change | 111 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 12 | Minimally Worse | 16 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 12 | Much Worse | 1 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 12 | Very Much Improved | 38 Participants |
Secondary
Percentage of Participants With a Migraine on the Day After Dosing
The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment Day and Day 1 is the day after dosing.
Time frame: Day 1
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 300 mg ALD403 | Percentage of Participants With a Migraine on the Day After Dosing | 27.8 Percentage of participants |
| 100 mg ALD403 | Percentage of Participants With a Migraine on the Day After Dosing | 28.6 Percentage of participants |
| Placebo | Percentage of Participants With a Migraine on the Day After Dosing | 42.3 Percentage of participants |
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Percent Change in Frequency of Headache Days - Week 1-12
The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Percent Change in Frequency of Headache Days - Week 1-12 | -44.1 percent change of headache days | Standard Deviation 30.59 |
| 100 mg ALD403 | Percent Change in Frequency of Headache Days - Week 1-12 | -41.2 percent change of headache days | Standard Deviation 29.2 |
| Placebo | Percent Change in Frequency of Headache Days - Week 1-12 | -31.4 percent change of headache days | Standard Deviation 28.62 |
Secondary
Percent Change in Frequency of Migraine Days - Week 1-12
The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12.
Time frame: Week 1-12
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Percent Change in Frequency of Migraine Days - Week 1-12 | -53.5 percent change of migraine days | Standard Deviation 35.46 |
| 100 mg ALD403 | Percent Change in Frequency of Migraine Days - Week 1-12 | -48.6 percent change of migraine days | Standard Deviation 36.6 |
| Placebo | Percent Change in Frequency of Migraine Days - Week 1-12 | -34.5 percent change of migraine days | Standard Deviation 38.17 |
Secondary
Time to First Migraine After Dosing
The time to first migraine after dosing based upon the migraine data entered into the eDiary
Time frame: 32 weeks
Population: Full Analysis Population - all randomized participants who received investigational product or placebo
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 300 mg ALD403 | Time to First Migraine After Dosing | 4.0 days |
| 100 mg ALD403 | Time to First Migraine After Dosing | 4.0 days |
| Placebo | Time to First Migraine After Dosing | 2.0 days |