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

NCT02985398 | Completed Phase 3 Results

• 1 other identifier: ALD403-CLIN-013
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Migraine Disorder

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)

  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.

  104 Weeks

• Number of Participants With a Clinically Significant Electrocardiogram

  Overall investigator interpretation of participant electrocardiogram

  Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104

• Number of Participants With Any Clinically Significant Laboratory Values

  Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.

  104 Weeks

• Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)

  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.

  104 Weeks

• Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs

  Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator

  104 Weeks

Secondary Outcomes (8)

• Patient Global Impression of Change (PGIC) at Week 104

  Week 104

• Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores

  Baseline to Week 12

• Health Related Quality of Life (EQ-5D-5L) at Week 12

  Week 12

• Change in Baseline of Headache Impact Test (HIT-6) Score

  Baseline, Week 1-4, Week 9-12

• Change in Most Bothersome Symptom at Week 48

  Baseline to Week 48

Study Arms (1)

ALD403 (Eptinezumab) Dose Level 1

EXPERIMENTAL

ALD403 (Eptinezumab) Dose Level 1 (IV)

Biological: ALD403 (Eptinezumab)

Interventions

ALD403 (Eptinezumab) BIOLOGICAL

Also known as: Eptinezumab-jjmr, Vyepti

ALD403 (Eptinezumab) Dose Level 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alder Biopharmaceuticals, Inc.: lead

Study Sites (20)

Research Site

San Diego, California, 92108, United States

Location

Research Site

Santa Monica, California, 90404, United States

Location

Research Site

Colorado Springs, Colorado, 80918, United States

Location

Research Site

Bradenton, Florida, 34201, United States

Location

Research Site

DeLand, Florida, 32720, United States

Location

Massachusetts

Miami, Florida, 33125, United States

Location

Research Site

Tampa, Florida, 33634, United States

Location

Research Site

Winter Haven, Florida, 33880, United States

Location

Research Site

Prairie Village, Kansas, 66206, United States

Location

Massachusetts

Boston, Massachusetts, 02131, United States

Location

Research Site

North Attleboro, Massachusetts, 02760, United States

Location

02481

Wellesley, Massachusetts, 02481, United States

Location

Research Site

Minneapolis, Minnesota, 55402, United States

Location

Research Site

Brooklyn, New York, 11229, United States

Location

Research Site

Rochester, New York, 14609, United States

Location

Research Site

Dayton, Ohio, 45432, United States

Location

Research Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Research Site

Chattanooga, Tennessee, 37421, United States

Location

Research Site

Fort Worth, Texas, 76104, United States

Location

Research Site

Bellevue, Washington, 98007, United States

Location

Related Publications (3)

• 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.

  PMID: 35804294 DERIVED

• 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.

  PMID: 33781209 DERIVED

• 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.

  PMID: 33740902 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Locations

US (20)