An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine

Phase 3

Completed

• Conditions: Migraine Disorder
• Interventions: Biological: ALD403 (Eptinezumab)

• Registration Number: NCT02985398
• Lead Sponsor: Alder Biopharmaceuticals, Inc.

Brief Summary

An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-07
• Primary Completion: 2018-04
• Study Completion: 2019-03
• Disposition First Submitted: 2019-05-01
• Disposition First Submitted QC: 2019-05-01
• Disposition First Posted: 2019-05-03
• Results First Submitted: 2020-03-20
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Results First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALD403 (Eptinezumab) Dose Level 1	ALD403 (Eptinezumab)	ALD403 (Eptinezumab) Dose Level 1 (IV)

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)	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	104 Weeks	Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)	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	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	104 Weeks	Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC) at Week 104	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.
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit	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.
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores	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	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.
Development of Anti-ALD403 Antibody by Visit	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.
Change in Most Bothersome Symptom at Week 48	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 in Baseline of Headache Impact Test (HIT-6) Score	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 From Baseline of Migraine Disability Assessment (MIDAS) Total Score	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.

Trial Locations

Locations (3)

02481; 🇺🇸 Wellesley, Massachusetts, United States

Research Site; 🇺🇸 Bellevue, Washington, United States

Massachusetts; 🇺🇸 Boston, Massachusetts, United States