Phase 3
Completed N=128
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine
Migraine Disorder
Source: ClinicalTrials.gov NCT02985398 ↗
Enrolled (actual)
128
Serious AEs
3.9%
Results posted
Apr 2020
Primary outcomePrimary: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) — 91 Participants
◆ Published Evidence
Established
96citations · ~19 / year
Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial.
Summary
An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
Linked Publications (4)
-
Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial.
-
Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials.
-
Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab.
-
Long-Term Reductions in Headache Frequency, Severity, and Disability with Eptinezumab in Adults with Chronic Migraine: Results from the PREVAIL Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.