| Primary | 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. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Count of Participants | | Participants | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo | Participants received a single placebo IV infusion on Day 0 |
| | Units | Counts |
|---|
| Participants | - OG000114
- OG001118
- OG002117
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00038
- OG00137
- OG00233
- 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 |
|---|
| | Cochran-Mantel-Haenszel | | 0.0330 | | Mean Difference (Final Values) | 12.6 | | | 2-Sided | 95 | 1.3 | 24.0 | | | | | Superiority | 75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population) | | | | Cochran-Mantel-Haenszel |
|
| 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 | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Count of Participants | | Participants | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| 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 | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Count of Participants | | Participants | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| Secondary | 100% Headache Responder Rate | Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Count of Participants | | Participants | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| Secondary | 100% Migraine Responder Rate | Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Count of Participants | | Participants | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| Secondary | The Change From Baseline in Monthly Headache Days, Weeks 1-12 | Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | days | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| Secondary | The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | days | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| 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 | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | percentage of severe migraines | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 |
|
| Secondary | Change From Baseline in Percentage of Severe Headaches | The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12 | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | percentage of severe headaches | | Weeks 9-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 |
|
| Secondary | The Change From Baseline to Week 12 in HIT-6 Total 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). A score of 60 or above is labeled as "severe". | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Number | | percentage of HIT-6 total score | | Baseline to 12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 |
|
| Secondary | Percent Change From Baseline in Headache Days | Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | percentage of headache days | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| Secondary | Percent Change From Baseline in Migraine Days | Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | percentage of migraine days | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo |
|
| Secondary | Time to First Migraine After Dosing | The median number of days after dosing a participant had the next migraine using the eDiary as the recall method | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Number | 95% Confidence Interval | Days | | Baseline to Week 49 (End of Study) | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 |
|
| Secondary | Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | The number of monthly migraine attacks summarized over Weeks 1-12. A migraine attack is defined as 1 continuously recorded migraine. One attack may result in multiple migraine days | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | Migraine Attacks | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | |
|
| Secondary | Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | The number of monthly headache episodes as summarized over Weeks 1-12. A headache episode is defined as 1 continuously recorded headache. One episode may result in multiple headache days | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | Headache Episodes | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 |
|
| 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. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | Migraine Hours | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 |
|
| 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. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | Headache Hours | | Weeks 1-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 |
|
| Secondary | Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero. | | Posted | | Mean | Standard Deviation | percentage of acute medication migraines | | Weeks 9-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | | OG004 | Placebo | Participants received a single placebo IV infusion on Day 0 |
|
| Secondary | Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | percentage of acute medication headaches | | Weeks 9-12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 | |
|
| Secondary | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at 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 (range: 0=worst to 100=best). Increases from baseline indicate improvement. | Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor. | Posted | | Mean | Standard Deviation | SF-36 Score | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 300 mg ALD403 | Participants received a single 300 mg IV infusion of ALD403 on Day 0 | | OG001 | 100 mg ALD403 | Participants received a single 100 mg IV infusion of ALD403 on Day 0 | | OG002 | 30 mg ALD403 | Participants received a single 30 mg IV infusion of ALD403 on Day 0 | | OG003 | 10 mg ALD403 | Participants received a single 10 mg IV infusion of ALD403 on Day 0 |
|