A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days (MMDs) Over 12 Weeks of Treatment With CGRP mAbs and Onabotulinumtoxin A Intramuscularly Compared With CGRP mAbs and Placebo in Chronic Migraine

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. Chronic migraine, which occurs in 1-2 % of the population is characterized by 15 or more headache days/month for more than 3 months and at least 8 days/month with features of migraine headache. The study will evaluate the efficacy of onabotulinumtoxin A when added to CGRP monoclonal antibody therapy in chronic migraine prevention. Adverse events and change in disease activity will be monitored. Onabotulinumtoxin A and CGRP monoclonal antibody therapy are investigational drugs developed to prevent chronic migraine. Approximately 450 patients will be included from sites in Norway. All participants will receive CGRP monoclonal antibody therapy. Additionally, the participants will be randomized to receive onabotulinumtoxin A or placebo injections. Total study duration is 20 weeks including 3 on site visits and 3 telephone visits. After an inclusion visit the participants are registering data in an electronic headache diary using the application Brain Twin for a minimum of 4 weeks before the come to the randomization visit and the study medications are started. The duration of treatment is 12 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Informed and signed written consent.

• Individuals of any sex, 18-70 years at the time of signing the informed consent.

• Fulfilling the diagnosis chronic migraine criteria 1.3. according to the International Classification of Headache Disorders version 3 at time of inclusion.

• Indications for treatment with CGRP mAbs according to SmPCs.

• Indications for treatment with BTA according to SmPC.

• No previous use of CGRP inhibitors or BTA.

• Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method

Locations
Other Locations
Norway
Østfold Hospital Trust
NOT_YET_RECRUITING
Grålum
Sørlandet Hospital Kristiansand
NOT_YET_RECRUITING
Kristiansand
Innlandet Hospital Trust Lillehammer
NOT_YET_RECRUITING
Lillehammer
Oslo University Hospital
RECRUITING
Oslo
Telemark Hospital Trust Skien
NOT_YET_RECRUITING
Skien
St. Olav University Hospital
NOT_YET_RECRUITING
Trondheim
Contact Information
Primary
Anne Hege Aamodt, Prof, MD, PhD
a.h.aamodt@medisin.uio.no
+47 95867270
Backup
Burcu Bezgal, Neurologist PhD student
burbez@ous-hf.no
+47 471 51 876‬
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 450
Treatments
Placebo_comparator: CGRP and placebo
Combination of CGRP mAbs and placebo (NaCl 0.9% Braun, 0.1 ml at the same sites) in male and female participants with chronic migraine aged 18 to 70 years.
Active_comparator: CGRP and onabotulinumtoxin A
Onabotulinumtoxin A given totally 155 units at 31 sites according to modified PREEMPT or placebo (NaCl 0.9% Braun, 0.1 ml at the same sites). The treatment period is 12 weeks long.
Related Therapeutic Areas
Sponsors
Collaborators: St. Olavs Hospital, Sykehuset Innlandet HF, Ostfold Hospital Trust, Sorlandet Hospital HF, Sykehuset Telemark
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov

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