| Primary | Change From Baseline in Monthly Migraine Days (Weeks 1-12) | 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 | Standard Deviation | 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| | Units | Counts |
|---|
| Participants | - OG000222
- OG001221
- OG002223
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-4.3± 3.42
- OG001-3.9± 3.23
- OG002-4.1± 3.22
- OG003
|
|
| | 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 |
|---|
| | ANCOVA | | 0.0001 | | Mean Difference (Final Values) | -1.11 | Standard Deviation | 3.40 | 2-Sided | 95 | -1.68 | -0.54 | | | | | Superiority | | | | | ANCOVA | | 0.0182 |
|
| 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| Secondary | 75% Migraine Responder Rate | 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| 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 | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| Secondary | 100% Migraine Responder Rate | Participants with a reduction in migraine days of 100% 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| Secondary | 100% Headache Responder Rate | Participants with a reduction in headache days of 100% 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| Secondary | Change From Baseline in Acute Migraine Medication Days (Weeks 1-12) | The change in number of days 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 | days | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| Secondary | Change From Baseline in Average Daily Migraine Prevalence to Week 4 | The change in the percentage of days where a participant has a migraine from baseline to Week 4. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percentage of days with migraine | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| 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 migraines 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|
| Secondary | Percent of Headaches With Severe Intensity | Summary of percent of headaches with severe intensity over Weeks 1-12. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percentage of severe intensity headaches | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| Secondary | Percent of Migraines With Severe Intensity | Summary of percent of migraines with severe intensity over Week 1-12. | Full Analysis Population - all randomized participants who received investigational product or placebo | Posted | | Mean | Standard Deviation | percentage of severe intensity migraines | | Week 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| Secondary | Change From Baseline in Monthly Migraine Hours (Weeks 1-12) | Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals. | | 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| 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. | | 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 | Placebo | Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
| |
| 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. The Week 12 scores only include participants who completed the Week 12 visit. | 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG003 |
|
| 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 dimension/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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | |
|
| Secondary | Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score | The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe. | 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 | | 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, 84 (Week 12), 168 (Week 24) and 252 (Week 36). | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). |
|