Phase 3
N=128
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine
Migraine Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02985398 ↗Enrolled (actual)
128
Serious AEs
3.9%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) — 91 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALD403 (Eptinezumab) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alder Biopharmaceuticals, Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) |
91 | — |
| PRIMARY Number of Participants With a Clinically Significant Electrocardiogram |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Any Clinically Significant Laboratory Values |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) |
0; 0 | — |
| PRIMARY Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs |
0; 0; 0 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 104 |
47; 33; 11; 5; 0; 0 | — |
| SECONDARY Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores |
5.8; 1.6; 1.9; 1.4; 4.5; 2.9 | — |
| SECONDARY Health Related Quality of Life (EQ-5D-5L) at Week 12 |
110; 11; 3; 0; 0; 121 | — |
| SECONDARY Change in Baseline of Headache Impact Test (HIT-6) Score |
-8.0; -7.9 | — |
| SECONDARY Change in Most Bothersome Symptom at Week 48 |
40; 44; 17; 11; 0; 0 | — |
| SECONDARY Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score |
-36.3 | — |
| SECONDARY Development of Anti-ALD403 Antibody by Visit |
0; 128; 1; 126; 0; 126 | — |
| SECONDARY Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit |
0; 0; 0; 1; 0; 0 | — |
Summary
An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02985398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.