| Primary | Change From Baseline in Monthly Migraine Days | Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12 | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Full Range | Migraine Days | | Week 1-12 | | | | ID | Title | Description |
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| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-8.2(-23 to 11)
- OG001-7.7(-22 to 10)
- OG002-5.6(-25 to 9)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | <0.0001 | | Mean Difference (Final Values) | -2.60 | Standard Deviation | 6.15 | 2-Sided | 95 | -3.45 | -1.74 | | | | | Superiority | | | | | ANCOVA | | <0.0001 |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Count of Participants | | Participants | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Count of Participants | | Participants | | Week 1-4 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Count of Participants | | Participants | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Number | | Percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | Acute Medication Migraine Days | | Week 1-12 | | | | ID | Title | Description |
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| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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). | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Full Range | score on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | 95% Confidence Interval | percentage of participants with migraine | | Baseline to Week 4 | | | | ID | Title | Description |
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| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Count of Participants | | Participants | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Count of Participants | | Participants | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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%. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Number | | percent of participants | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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%. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Number | | Percent of participants | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | Migraine Days | | Week 13-24 | | | | ID | Title | Description |
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| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | Headache Days | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| Secondary | Time to First Migraine After Dosing | The time to first migraine after dosing based upon the migraine data entered into the eDiary | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Median | Inter-Quartile Range | days | | 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percentage of acute medication migraines | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percentage of acute medication headaches | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percent change of migraine days | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percent change of headache days | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percentage of migraines scored "severe" | | Week 1-12 | | | | ID | Title | Description |
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| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percentage of headaches scored "severe" | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | migraine hours | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | headache hours | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Count of Participants | | Participants | | 32 weeks | | | | ID | Title | Description |
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| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12). | | OG002 | Placebo | Participants received a single placebo IV infusion on Days 0 and 84 (Week 12). |
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