Clinical trial NCT02985398: An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine
Official title: An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorder
Lead sponsor: Alder Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
timeFrame: 104 Weeks
measure: Number of Participants With a Clinically Significant Electrocardiogram
timeFrame: Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104
measure: Number of Participants With Any Clinically Significant Laboratory Values
timeFrame: 104 Weeks
measure: Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 104 Weeks
measure: Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs
timeFrame: 104 Weeks
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC) at Week 104
timeFrame: Week 104
measure: Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
timeFrame: Baseline to Week 12
measure: Health Related Quality of Life (EQ-5D-5L) at Week 12
timeFrame: Week 12
measure: Change in Baseline of Headache Impact Test (HIT-6) Score
timeFrame: Baseline, Week 1-4, Week 9-12
measure: Change in Most Bothersome Symptom at Week 48
timeFrame: Baseline to Week 48
measure: Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score
timeFrame: Baseline to Week 12
measure: Development of Anti-ALD403 Antibody by Visit
timeFrame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104
measure: Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit
timeFrame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Massachusetts
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Winter Haven
country: United States
facility: Research Site
state: Florida
city: Prairie Village
country: United States
facility: Research Site
state: Kansas
city: Boston
country: United States
facility: Massachusetts
state: Massachusetts
city: North Attleboro
country: United States
facility: Research Site
state: Massachusetts
city: Wellesley
country: United States
facility: 02481
state: Massachusetts
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Bellevue
country: United States
facility: Research Site
state: Washington
Study officials:
References:
citation: Blumenfeld A, Ettrup A, Hirman J, Ebert B, Cady R. Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurol. 2022 Jul 8;22(1):251. doi: 10.1186/s12883-022-02774-3.
citation: Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.
citation: Kudrow D, Cady RK, Allan B, Pederson SM, Hirman J, Mehta LR, Schaeffler BA. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021 Mar 19;21(1):126. doi: 10.1186/s12883-021-02123-w.