An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PREVAIL)
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|ClinicalTrials.gov Identifier: NCT02985398|
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorder||Biological: ALD403 (Eptinezumab)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||March 2019|
Experimental: ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
Biological: ALD403 (Eptinezumab)
- Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 104 Weeks ]Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion.
- Number of Participants With a Clinically Significant Electrocardiogram [ Time Frame: Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104 ]Overall investigator interpretation of participant electrocardiogram
- Number of Participants With Any Clinically Significant Laboratory Values [ Time Frame: 104 Weeks ]Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.
- Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 104 Weeks ]Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits.
- Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs [ Time Frame: 104 Weeks ]Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator
- Patient Global Impression of Change (PGIC) at Week 104 [ Time Frame: Week 104 ]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.
- Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores [ Time Frame: Baseline to Week 12 ]The SF-36 is a health survey consisting of 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (scale range: 0=worst to 100=best). Increases from baseline indicate improvement.
- Health Related Quality of Life (EQ-5D-5L) at Week 12 [ Time Frame: Week 12 ]The EQ-5D-5L is a descriptive 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.
- Change in Baseline of Headache Impact Test (HIT-6) Score [ Time Frame: Baseline, Week 1-4, Week 9-12 ]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 assess over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). The change in baseline will be calculated from the average scores.
- Change in Most Bothersome Symptom at Week 48 [ Time Frame: Baseline to Week 48 ]The Investigator verbally obtained the most bothersome symptom associated with the participant's migraine during the screening visit. The most bothersome symptom may include nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, or other migraine related symptoms. Participants were asked to rate the improvement in this symptom from screening on a seven-point scale.
- Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score [ Time Frame: Baseline to Week 12 ]
The MIDAS questionnaire measures the effect headaches have on the participant's daily functioning. MIDAS is composed of five questions that ask about the participant's performance over the past 3 months. The response to each question is provided in number of days which are summed to determine the MIDAS total score and level of disability:
0-5, MIDAS Grade I, little or no disability; 6-10, MIDAS Grade II, mild disability; 11-20, MIDAS Grade III, moderate disability; 21+, MIDAS Grade IV, severe disability;
A higher value represents a worse outcome.
- Development of Anti-ALD403 Antibody by Visit [ Time Frame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 ]Serum blood samples were taken at visits to test for the development of antibodies to ALD403, or anti-drug antibodies (ADA). Participants who tested positive for anti-ALD403 antibodies at the time of the last study visit were asked to provide up to 2 additional blood samples for immunogenicity testing at approximately 3 month intervals for up to 6 months.
- Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit [ Time Frame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 ]Any samples that were positive for anti-ALD403 antibody, there was additional testing to characterize the anti-ALD403 antibody for the potential to neutralize (NAb) ALD403 activity.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
- Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
- Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
- Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
- History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985398
|United States, California|
|San Diego, California, United States, 92108|
|Santa Monica, California, United States, 90404|
|United States, Colorado|
|Colorado Springs, Colorado, United States, 80918|
|United States, Florida|
|Bradenton, Florida, United States, 34201|
|DeLand, Florida, United States, 32720|
|Miami, Florida, United States, 33125|
|Tampa, Florida, United States, 33634|
|Winter Haven, Florida, United States, 33880|
|United States, Kansas|
|Prairie Village, Kansas, United States, 66206|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02131|
|North Attleboro, Massachusetts, United States, 02760|
|Wellesley, Massachusetts, United States, 02481|
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55402|
|United States, New York|
|Brooklyn, New York, United States, 11229|
|Rochester, New York, United States, 14609|
|United States, Ohio|
|Dayton, Ohio, United States, 45432|
|United States, South Carolina|
|Mount Pleasant, South Carolina, United States, 29464|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37421|
|United States, Texas|
|Fort Worth, Texas, United States, 76104|
|United States, Washington|
|Bellevue, Washington, United States, 98007|
Documents provided by Alder Biopharmaceuticals, Inc.:
|Responsible Party:||Alder Biopharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 7, 2016 Key Record Dates|
|Results First Posted:||April 21, 2020|
|Last Update Posted:||April 21, 2020|
|Last Verified:||April 2020|
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases