Migraine Disorders
Conditions
Keywords
Migraine Disorders, ALD403
Brief summary
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.
Interventions
BIOLOGICALALD403
BIOLOGICALPlacebo
Sponsors
Alder Biopharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year * During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary * Headache eDiary was completed on at least 22 of the 28 days prior to randomization
Exclusion criteria
* Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome) or any pain syndrome that requires regular analgesia * Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. * History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine * Unable to differentiate migraine from other headaches * Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening. * Have any clinically significant concurrent medical condition * Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial) * Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 75% Migraine Responder Rate | 12 Weeks | Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 50% Headache Responder Rate | Weeks 1-12 | Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline |
| 100% Headache Responder Rate | Weeks 1-12 | Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline |
| 100% Migraine Responder Rate | Weeks 1-12 | Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline |
| The Change From Baseline in Monthly Headache Days, Weeks 1-12 | Weeks 1-12 | Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. |
| The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | Weeks 1-12 | Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. |
| Change From Baseline in Percentage of Severe Migraines | Weeks 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 Headaches | Weeks 9-12 | The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12 |
| The Change From Baseline to Week 12 in HIT-6 Total Score | Baseline to 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). A score of 60 or above is labeled as severe. |
| Percent Change From Baseline in Headache Days | Weeks 1-12 | Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. |
| 50% Migraine Responder Rate | Weeks 1-12 | Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline |
| Time to First Migraine After Dosing | Baseline to Week 49 (End of Study) | The median number of days after dosing a participant had the next migraine using the eDiary as the recall method |
| Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | 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 |
| Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | 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 |
| Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | 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. |
| Change From Baseline in Monthly Headache Hours, Weeks 1-12 | 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. |
| Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | Weeks 9-12 | The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero. |
| Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | Weeks 9-12 | The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero. |
| Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | 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 (range: 0=worst to 100=best). Increases from baseline indicate improvement. |
| Percent Change From Baseline in Migraine Days | Weeks 1-12 | Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. |
Countries
Australia, Georgia, New Zealand, United States
Participant flow
Pre-assignment details
A total of 1552 participants signed the ICF, of which 665 participants met the entry criteria and were randomized into the trial.
Participants by arm
| Arm | Count |
|---|---|
| 300 mg ALD403 Participants received a single 300 mg IV infusion of ALD403 on Day 0 | 121 |
| 100 mg ALD403 Participants received a single 100 mg IV infusion of ALD403 on Day 0 | 122 |
| 30 mg ALD403 Participants received a single 30 mg IV infusion of ALD403 on Day 0 | 122 |
| 10 mg ALD403 Participants received a single 10 mg IV infusion of ALD403 on Day 0 | 130 |
| Placebo Participants received a single placebo IV infusion on Day 0 | 121 |
| Total | 616 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 6 | 7 | 5 | 2 | 10 |
| Overall Study | Lost to Follow-up | 11 | 16 | 15 | 16 | 8 |
| Overall Study | Other | 1 | 0 | 0 | 0 | 2 |
| Overall Study | Physician Decision | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Study Burden | 5 | 4 | 7 | 5 | 7 |
| Overall Study | Terminated by Sponsor | 4 | 4 | 4 | 6 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 4 | 7 | 3 | 3 |
| Overall Study | Worsening of Study Indication | 0 | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | 300 mg ALD403 | 100 mg ALD403 | 30 mg ALD403 | 10 mg ALD403 | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 10 | 36.7 years STANDARD_DEVIATION 9.4 | 35.7 years STANDARD_DEVIATION 9.4 | 36.4 years STANDARD_DEVIATION 10.3 | 37.2 years STANDARD_DEVIATION 9.2 | 36.6 years STANDARD_DEVIATION 19.7 |
| Baseline Migraine Days < 20 days | 84 Participants | 85 Participants | 87 Participants | 90 Participants | 84 Participants | 430 Participants |
| Baseline Migraine Days ≥ 20 days | 37 Participants | 37 Participants | 35 Participants | 40 Participants | 37 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 23 Participants | 17 Participants | 27 Participants | 16 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 99 Participants | 105 Participants | 103 Participants | 105 Participants | 515 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Medication Overuse Status No | 56 Participants | 62 Participants | 57 Participants | 64 Participants | 57 Participants | 296 Participants |
| Medication Overuse Status Yes | 65 Participants | 60 Participants | 65 Participants | 66 Participants | 64 Participants | 320 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 12 Participants | 14 Participants | 12 Participants | 7 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) White | 114 Participants | 108 Participants | 103 Participants | 113 Participants | 109 Participants | 547 Participants |
| Region of Enrollment Australia | 2 participants | 6 participants | 1 participants | 5 participants | 5 participants | 19 participants |
| Region of Enrollment Georgia | 11 participants | 9 participants | 14 participants | 9 participants | 15 participants | 58 participants |
| Region of Enrollment New Zealand | 7 participants | 1 participants | 0 participants | 1 participants | 2 participants | 11 participants |
| Region of Enrollment United States | 101 participants | 106 participants | 107 participants | 115 participants | 99 participants | 528 participants |
| Sex: Female, Male Female | 98 Participants | 104 Participants | 111 Participants | 113 Participants | 109 Participants | 535 Participants |
| Sex: Female, Male Male | 23 Participants | 18 Participants | 11 Participants | 17 Participants | 12 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 122 | 0 / 122 | 0 / 130 | 0 / 121 |
| other Total, other adverse events | 40 / 121 | 38 / 122 | 26 / 122 | 35 / 130 | 37 / 122 |
| serious Total, serious adverse events | 7 / 121 | 4 / 122 | 0 / 122 | 1 / 130 | 1 / 121 |
Outcome results
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.
Time frame: 12 Weeks
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 75% Migraine Responder Rate | 38 Participants |
| 100 mg ALD403 | 75% Migraine Responder Rate | 37 Participants |
| 30 mg ALD403 | 75% Migraine Responder Rate | 33 Participants |
| 10 mg ALD403 | 75% Migraine Responder Rate | 33 Participants |
| Placebo | 75% Migraine Responder Rate | 24 Participants |
p-value: 0.03395% CI: [1.3, 24]Cochran-Mantel-Haenszel
p-value: 0.071595% CI: [-0.5, 21.8]Cochran-Mantel-Haenszel
p-value: 0.201395% CI: [-3.5, 18.5]Cochran-Mantel-Haenszel
p-value: 0.293895% CI: [-4.6, 16.9]Cochran-Mantel-Haenszel
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
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 100% Headache Responder Rate | 4 Participants |
| 100 mg ALD403 | 100% Headache Responder Rate | 0 Participants |
| 30 mg ALD403 | 100% Headache Responder Rate | 0 Participants |
| 10 mg ALD403 | 100% Headache Responder Rate | 1 Participants |
| Placebo | 100% Headache Responder Rate | 1 Participants |
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
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 100% Migraine Responder Rate | 9 Participants |
| 100 mg ALD403 | 100% Migraine Responder Rate | 6 Participants |
| 30 mg ALD403 | 100% Migraine Responder Rate | 5 Participants |
| 10 mg ALD403 | 100% Migraine Responder Rate | 10 Participants |
| Placebo | 100% Migraine Responder Rate | 3 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: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 50% Headache Responder Rate | 59 Participants |
| 100 mg ALD403 | 50% Headache Responder Rate | 55 Participants |
| 30 mg ALD403 | 50% Headache Responder Rate | 55 Participants |
| 10 mg ALD403 | 50% Headache Responder Rate | 48 Participants |
| Placebo | 50% Headache Responder Rate | 39 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: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | 50% Migraine Responder Rate | 65 Participants |
| 100 mg ALD403 | 50% Migraine Responder Rate | 65 Participants |
| 30 mg ALD403 | 50% Migraine Responder Rate | 65 Participants |
| 10 mg ALD403 | 50% Migraine Responder Rate | 54 Participants |
| Placebo | 50% Migraine Responder Rate | 47 Participants |
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.
Time frame: Baseline to Week 12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Baseline | 45.0 SF-36 Score | Standard Deviation 10.8 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Baseline | 50.2 SF-36 Score | Standard Deviation 9.1 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain -Baseline | 42.7 SF-36 Score | Standard Deviation 9.5 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Baseline | 45.5 SF-36 Score | Standard Deviation 8.4 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Week 12 | 53.6 SF-36 Score | Standard Deviation 5 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Baseline | 50.4 SF-36 Score | Standard Deviation 9.4 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Baseline | 43.9 SF-36 Score | Standard Deviation 9.5 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain - Week 12 | 48.9 SF-36 Score | Standard Deviation 8.4 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Week 12 | 50.5 SF-36 Score | Standard Deviation 8.1 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Week 12 | 51.2 SF-36 Score | Standard Deviation 6.8 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Week 12 | 52.1 SF-36 Score | Standard Deviation 8.8 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Baseline | 50.5 SF-36 Score | Standard Deviation 8.7 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Baseline | 50.4 SF-36 Score | Standard Deviation 9.2 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Baseline | 51.4 SF-36 Score | Standard Deviation 8.4 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Week 12 | 51.2 SF-36 Score | Standard Deviation 9 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Week 12 | 51.8 SF-36 Score | Standard Deviation 8.7 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Week 12 | 51.3 SF-36 Score | Standard Deviation 7.8 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Week 12 | 50.9 SF-36 Score | Standard Deviation 7.2 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Week 12 | 51.4 SF-36 Score | Standard Deviation 8.2 |
| 300 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Baseline | 48.3 SF-36 Score | Standard Deviation 8.9 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Baseline | 49.4 SF-36 Score | Standard Deviation 9.6 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Baseline | 50.1 SF-36 Score | Standard Deviation 10.6 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Week 12 | 48.7 SF-36 Score | Standard Deviation 10.1 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Week 12 | 50.9 SF-36 Score | Standard Deviation 10.5 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Week 12 | 51.2 SF-36 Score | Standard Deviation 8.3 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Baseline | 46.3 SF-36 Score | Standard Deviation 10.1 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Week 12 | 49.0 SF-36 Score | Standard Deviation 8.6 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Week 12 | 50.5 SF-36 Score | Standard Deviation 9.7 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Baseline | 45.2 SF-36 Score | Standard Deviation 9.3 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Baseline | 50.9 SF-36 Score | Standard Deviation 9.7 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Week 12 | 48.9 SF-36 Score | Standard Deviation 9.3 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Baseline | 50.6 SF-36 Score | Standard Deviation 7.8 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain -Baseline | 42.7 SF-36 Score | Standard Deviation 9.6 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Baseline | 50.7 SF-36 Score | Standard Deviation 9.8 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Week 12 | 50.8 SF-36 Score | Standard Deviation 10.1 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain - Week 12 | 46.5 SF-36 Score | Standard Deviation 9.9 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Baseline | 52.0 SF-36 Score | Standard Deviation 9.3 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Week 12 | 50.2 SF-36 Score | Standard Deviation 9 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Week 12 | 50.7 SF-36 Score | Standard Deviation 10.2 |
| 100 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Baseline | 46.1 SF-36 Score | Standard Deviation 8.4 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Week 12 | 50.7 SF-36 Score | Standard Deviation 9.4 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Baseline | 50.9 SF-36 Score | Standard Deviation 8.7 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Baseline | 51.1 SF-36 Score | Standard Deviation 7.6 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Week 12 | 52.5 SF-36 Score | Standard Deviation 7.2 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Baseline | 45.6 SF-36 Score | Standard Deviation 9.3 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Week 12 | 49.9 SF-36 Score | Standard Deviation 7.7 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain -Baseline | 44.5 SF-36 Score | Standard Deviation 9.9 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain - Week 12 | 48.1 SF-36 Score | Standard Deviation 9.2 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Week 12 | 50.7 SF-36 Score | Standard Deviation 9.2 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Baseline | 49.6 SF-36 Score | Standard Deviation 9.8 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Week 12 | 50.6 SF-36 Score | Standard Deviation 11.3 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Baseline | 46.8 SF-36 Score | Standard Deviation 10.7 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Week 12 | 49.5 SF-36 Score | Standard Deviation 9 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Baseline | 49.4 SF-36 Score | Standard Deviation 9.7 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Week 12 | 51.2 SF-36 Score | Standard Deviation 7.2 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Baseline | 51.8 SF-36 Score | Standard Deviation 9.5 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Week 12 | 51.2 SF-36 Score | Standard Deviation 9.5 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Baseline | 50.5 SF-36 Score | Standard Deviation 9.6 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Baseline | 47.1 SF-36 Score | Standard Deviation 7.7 |
| 30 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Week 12 | 50.1 SF-36 Score | Standard Deviation 7 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Baseline | 49.4 SF-36 Score | Standard Deviation 10.1 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Baseline | 46.1 SF-36 Score | Standard Deviation 8.3 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Baseline | 49.8 SF-36 Score | Standard Deviation 10.3 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Week 12 | 52.7 SF-36 Score | Standard Deviation 9.8 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Week 12 | 50.9 SF-36 Score | Standard Deviation 8.4 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Baseline | 51.1 SF-36 Score | Standard Deviation 9.5 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Baseline | 50.3 SF-36 Score | Standard Deviation 8.4 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Baseline | 51.4 SF-36 Score | Standard Deviation 9.5 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain - Week 12 | 46.6 SF-36 Score | Standard Deviation 9.3 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Week 12 | 52.2 SF-36 Score | Standard Deviation 9.5 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain -Baseline | 43.0 SF-36 Score | Standard Deviation 9.6 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Baseline | 50.4 SF-36 Score | Standard Deviation 9.9 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Baseline | 44.9 SF-36 Score | Standard Deviation 9.9 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Week 12 | 47.9 SF-36 Score | Standard Deviation 9.9 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Week 12 | 51.3 SF-36 Score | Standard Deviation 9.3 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Week 12 | 51.3 SF-36 Score | Standard Deviation 7.9 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Baseline | 45.5 SF-36 Score | Standard Deviation 10.4 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Week 12 | 50.7 SF-36 Score | Standard Deviation 10.6 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Week 12 | 48.8 SF-36 Score | Standard Deviation 8.5 |
| 10 mg ALD403 | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Week 12 | 47.7 SF-36 Score | Standard Deviation 9.8 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Week 12 | 48.1 SF-36 Score | Standard Deviation 8.7 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Week 12 | 50.6 SF-36 Score | Standard Deviation 10 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Baseline | 44.3 SF-36 Score | Standard Deviation 9.6 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Week 12 | 48.4 SF-36 Score | Standard Deviation 8.1 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Baseline | 50.9 SF-36 Score | Standard Deviation 8.1 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Week 12 | 51.1 SF-36 Score | Standard Deviation 10.2 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | General Health - Baseline | 50.7 SF-36 Score | Standard Deviation 9.8 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Component Score - Baseline | 45.5 SF-36 Score | Standard Deviation 7.9 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Baseline | 50.5 SF-36 Score | Standard Deviation 9 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Emotional - Week 12 | 51.0 SF-36 Score | Standard Deviation 8.3 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Baseline | 50.2 SF-36 Score | Standard Deviation 6.5 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain - Week 12 | 46.0 SF-36 Score | Standard Deviation 9.5 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Physical Functioning - Week 12 | 51.9 SF-36 Score | Standard Deviation 6.1 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Vitality - Baseline | 48.1 SF-36 Score | Standard Deviation 10.9 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Baseline | 50.8 SF-36 Score | Standard Deviation 9.8 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Social Functioning - Baseline | 45.4 SF-36 Score | Standard Deviation 10.3 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Bodily Pain -Baseline | 42.5 SF-36 Score | Standard Deviation 9.4 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Role Physical - Week 12 | 48.5 SF-36 Score | Standard Deviation 8.3 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Component Score - Week 12 | 51.5 SF-36 Score | Standard Deviation 8.9 |
| Placebo | Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | Mental Health - Week 12 | 52.4 SF-36 Score | Standard Deviation 8.8 |
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
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | -8.2 Headache Episodes | Standard Deviation 5.54 |
| 100 mg ALD403 | Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | -8.0 Headache Episodes | Standard Deviation 5.37 |
| 30 mg ALD403 | Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | -8.3 Headache Episodes | Standard Deviation 5.55 |
| 10 mg ALD403 | Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | -7.3 Headache Episodes | Standard Deviation 5.37 |
| Placebo | Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | -7.0 Headache Episodes | Standard Deviation 5.13 |
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: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -73.9 Headache Hours | Standard Deviation 101.53 |
| 100 mg ALD403 | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -60.9 Headache Hours | Standard Deviation 114.77 |
| 30 mg ALD403 | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -62.9 Headache Hours | Standard Deviation 81.89 |
| 10 mg ALD403 | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -47.5 Headache Hours | Standard Deviation 102.84 |
| Placebo | Change From Baseline in Monthly Headache Hours, Weeks 1-12 | -38.7 Headache Hours | Standard Deviation 99.26 |
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
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | -6.8 Migraine Attacks | Standard Deviation 5.4 |
| 100 mg ALD403 | Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | -6.5 Migraine Attacks | Standard Deviation 4.9 |
| 30 mg ALD403 | Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | -6.9 Migraine Attacks | Standard Deviation 5 |
| 10 mg ALD403 | Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | -6.2 Migraine Attacks | Standard Deviation 5.2 |
| Placebo | Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | -5.5 Migraine Attacks | Standard Deviation 5 |
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.
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -70.9 Migraine Hours | Standard Deviation 100.34 |
| 100 mg ALD403 | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -64.2 Migraine Hours | Standard Deviation 114.58 |
| 30 mg ALD403 | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -63.1 Migraine Hours | Standard Deviation 84.56 |
| 10 mg ALD403 | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -49.2 Migraine Hours | Standard Deviation 103.83 |
| Placebo | Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | -34.9 Migraine Hours | Standard Deviation 100.87 |
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
Time frame: Weeks 9-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Percentage of Severe Headaches | -19.91 percentage of severe headaches | Standard Deviation 25.8 |
| 100 mg ALD403 | Change From Baseline in Percentage of Severe Headaches | -10.36 percentage of severe headaches | Standard Deviation 28.004 |
| 30 mg ALD403 | Change From Baseline in Percentage of Severe Headaches | -12.17 percentage of severe headaches | Standard Deviation 30.197 |
| 10 mg ALD403 | Change From Baseline in Percentage of Severe Headaches | -11.42 percentage of severe headaches | Standard Deviation 30.517 |
| Placebo | Change From Baseline in Percentage of Severe Headaches | -6.48 percentage of severe headaches | Standard Deviation 27.211 |
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: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline in Percentage of Severe Migraines | -20.7 percentage of severe migraines | Standard Deviation 29.47 |
| 100 mg ALD403 | Change From Baseline in Percentage of Severe Migraines | -15.9 percentage of severe migraines | Standard Deviation 27.38 |
| 30 mg ALD403 | Change From Baseline in Percentage of Severe Migraines | -17.2 percentage of severe migraines | Standard Deviation 26.98 |
| 10 mg ALD403 | Change From Baseline in Percentage of Severe Migraines | -16.1 percentage of severe migraines | Standard Deviation 29.8 |
| Placebo | Change From Baseline in Percentage of Severe Migraines | -9.7 percentage of severe migraines | Standard Deviation 27.32 |
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.
Time frame: Weeks 9-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | -5.98 percentage of acute medication headaches | Standard Deviation 34.144 |
| 100 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | -3.27 percentage of acute medication headaches | Standard Deviation 34.419 |
| 30 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | 1.52 percentage of acute medication headaches | Standard Deviation 30.013 |
| 10 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | -3.14 percentage of acute medication headaches | Standard Deviation 32.853 |
| Placebo | Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | -3.42 percentage of acute medication headaches | Standard Deviation 32.89 |
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.
Time frame: Weeks 9-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | -15.43 percentage of acute medication migraines | Standard Deviation 39.121 |
| 100 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | -10.36 percentage of acute medication migraines | Standard Deviation 43.89 |
| 30 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | -4.44 percentage of acute medication migraines | Standard Deviation 37.746 |
| 10 mg ALD403 | Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | -10.03 percentage of acute medication migraines | Standard Deviation 40.46 |
| Placebo | Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | -9.60 percentage of acute medication migraines | Standard Deviation 37.451 |
Secondary
Percent Change From Baseline in Headache Days
Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Percent Change From Baseline in Headache Days | -46.12 percentage of headache days | Standard Deviation 31.481 |
| 100 mg ALD403 | Percent Change From Baseline in Headache Days | -43.09 percentage of headache days | Standard Deviation 33.912 |
| 30 mg ALD403 | Percent Change From Baseline in Headache Days | -44.37 percentage of headache days | Standard Deviation 28.62 |
| 10 mg ALD403 | Percent Change From Baseline in Headache Days | -37.20 percentage of headache days | Standard Deviation 34.112 |
| Placebo | Percent Change From Baseline in Headache Days | -34.02 percentage of headache days | Standard Deviation 30.97 |
Secondary
Percent Change From Baseline in Migraine Days
Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Percent Change From Baseline in Migraine Days | -48.88 percentage of migraine days | Standard Deviation 41.243 |
| 100 mg ALD403 | Percent Change From Baseline in Migraine Days | -46.79 percentage of migraine days | Standard Deviation 40.983 |
| 30 mg ALD403 | Percent Change From Baseline in Migraine Days | -46.74 percentage of migraine days | Standard Deviation 36.588 |
| 10 mg ALD403 | Percent Change From Baseline in Migraine Days | -40.80 percentage of migraine days | Standard Deviation 40.133 |
| Placebo | Percent Change From Baseline in Migraine Days | -35.37 percentage of migraine days | Standard Deviation 41.1 |
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.
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | The Change From Baseline in Monthly Headache Days, Weeks 1-12 | -9.6 days | Standard Deviation 6.94 |
| 100 mg ALD403 | The Change From Baseline in Monthly Headache Days, Weeks 1-12 | -8.9 days | Standard Deviation 6.79 |
| 30 mg ALD403 | The Change From Baseline in Monthly Headache Days, Weeks 1-12 | -9.2 days | Standard Deviation 6.33 |
| 10 mg ALD403 | The Change From Baseline in Monthly Headache Days, Weeks 1-12 | -7.5 days | Standard Deviation 6.93 |
| Placebo | The Change From Baseline in Monthly Headache Days, Weeks 1-12 | -6.9 days | Standard Deviation 6.37 |
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.
Time frame: Weeks 1-12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | -8.2 days | Standard Deviation 7 |
| 100 mg ALD403 | The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | -7.7 days | Standard Deviation 6.87 |
| 30 mg ALD403 | The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | -7.9 days | Standard Deviation 6.38 |
| 10 mg ALD403 | The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | -6.7 days | Standard Deviation 6.8 |
| Placebo | The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | -5.6 days | Standard Deviation 6.56 |
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.
Time frame: Baseline to 12
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 300 mg ALD403 | The Change From Baseline to Week 12 in HIT-6 Total Score | -60.4 percentage of HIT-6 total score |
| 100 mg ALD403 | The Change From Baseline to Week 12 in HIT-6 Total Score | -43.4 percentage of HIT-6 total score |
| 30 mg ALD403 | The Change From Baseline to Week 12 in HIT-6 Total Score | -34.9 percentage of HIT-6 total score |
| 10 mg ALD403 | The Change From Baseline to Week 12 in HIT-6 Total Score | -34.8 percentage of HIT-6 total score |
| Placebo | The Change From Baseline to Week 12 in HIT-6 Total Score | -28.4 percentage of HIT-6 total score |
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
Time frame: Baseline to Week 49 (End of Study)
Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 300 mg ALD403 | Time to First Migraine After Dosing | 4.0 Days |
| 100 mg ALD403 | Time to First Migraine After Dosing | 4.0 Days |
| 30 mg ALD403 | Time to First Migraine After Dosing | 3.0 Days |
| 10 mg ALD403 | Time to First Migraine After Dosing | 4.0 Days |
| Placebo | Time to First Migraine After Dosing | 2.0 Days |