Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients.
Albert Muñoz-Vendrell, Sergio Campoy, Edoardo Caronna...
https://pubmed.ncbi.nlm.nih.gov/37268904Actively Recruiting
Phase 3
Age: 18Years - 70Years
All Genders
ID07040813
A Randomized Placebo-controlled Double-blind Trial Comparing CGRP Monoclonal Antibody and Onabotulinumtoxin A Dual Therapy Versus CGRP Monoclonal Antibody Alone in Chronic Migraine
Led by Oslo University Hospital · Updated on 2025-06-27
450
Participants Needed
6
Research Sites
12 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
St. Olavs Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for chronic migraine, a condition marked by 15 or more headache days per month for over three months, with at least eight days featuring migraine symptoms. This trial aims to assess the effectiveness of combining onabotulinumtoxin A with CGRP monoclonal antibody therapy compared to CGRP therapy alone in preventing chronic migraine attacks. The study also monitors side effects and changes in disease activity, involving about 450 participants in Norway aged 18 to 70 years. Participants will all receive monthly CGRP monoclonal antibody injections as background treatment. They will be randomly assigned to receive either onabotulinumtoxin A injections (155 units at 31 muscle sites) or placebo injections following a modified PREEMPT protocol. The treatment period lasts 12 weeks. Before starting treatment, participants will record headache data using an electronic diary app for at least four weeks. The study includes three in-person visits and three telephone visits across a total of 20 weeks. During the study, participants keep detailed headache diaries to track frequency, intensity, medication use, and headache type. Telephone follow-ups at weeks 4 and 8 review treatment adherence and safety. After 12 weeks of treatment, a clinical visit assesses study outcomes, including changes in monthly migraine days and headache severity. Participants continue diary entries for an additional four weeks until the final telephone visit, marking the study's end. The primary outcome is the reduction in monthly migraine days over 12 weeks.
CONDITIONS
Brief Title
The Nordic Chronic Migraine Trial of CGRP Monoclonal Antibody and Onabotulinumtoxin A Dual Therapy Compared to CGRP mAbs Monotherapy
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Adults aged 18 to 70 years at consent.
- Diagnosis of chronic migraine according to International Classification of Headache Disorders version 3.
- Suitable for treatment with CGRP monoclonal antibodies as per guidelines.
- Suitable for treatment with botulinum toxin A as per guidelines.
- No previous use of CGRP inhibitors or botulinum toxin A.
- Women of childbearing potential must use highly effective contraception.
You will not qualify if you...
- Allergy or hypersensitivity to botulinum toxin A or CGRP monoclonal antibodies.
- Serious cardiovascular conditions such as recent heart attack, stroke, or unstable angina.
- Current medication overuse headache without completed withdrawal.
- Unable to distinguish migraine from other headaches.
- Participation in another clinical study of new drugs within 2 months before inclusion.
- Continuous headache without headache-free periods for over 1 year.
- Pregnancy, planning pregnancy, inability to use contraception, or breastfeeding.
- Severe comorbidities or frailty reducing life expectancy or increasing hospitalization risk.
- Dependence on alcohol or illicit drugs.
- Severe psychiatric disorders or other factors limiting ability to complete study tasks.
- Inability to understand or comply with study procedures throughout the study duration.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for inclusion and consent
Run-in Period
Duration - Minimum 4 weeks
Participants register headache data daily in an electronic diary before starting the study treatment.
1 baseline visit (in-person) followed by daily electronic diary entries
Treatment
Duration - 12 weeks
Participants receive monthly injections of CGRP monoclonal antibodies and either onabotulinumtoxin A or placebo injections according to the study group for migraine prevention.
3 in-person visits and 2 telephone visits for medication administration and follow-up
Follow-up
Duration - 4 weeks
Participants continue headache diary entries and have a final telephone visit to conclude the study assessments.
1 telephone visit
Trial Site Locations
Total: 6 locations
1
Østfold Hospital Trust
Grålum, Norway
Not Yet Recruiting
2
Sørlandet Hospital Kristiansand
Kristiansand, Norway
Not Yet Recruiting
3
Innlandet Hospital Trust Lillehammer
Lillehammer, Norway
Not Yet Recruiting
4
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
5
Telemark Hospital Trust Skien
Skien, Norway
Not Yet Recruiting
6
St. Olav University Hospital
Trondheim, Norway
Not Yet Recruiting
Loading map...
Research Team
A
Anne Hege Aamodt, Prof, MD, PhD
B
Burcu Bezgal, Neurologist PhD student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
The amyloid precursor protein: beyond amyloid.
Hui Zheng, Edward H Koo
https://pubmed.ncbi.nlm.nih.gov/16930452Blood Pressure in Patients With Migraine Treated With Monoclonal Anti-CGRP (Receptor) Antibodies: A Prospective Follow-up Study.
Simone de Vries Lentsch, Britt W H van der Arend, Antoinette Maassen VanDenBrink...
https://pubmed.ncbi.nlm.nih.gov/36195452Development of a fatigue scale.
T Chalder, G Berelowitz, T Pawlikowska...
https://pubmed.ncbi.nlm.nih.gov/8463991A subjective cognitive impairment scale for migraine attacks. The MIG-SCOG: development and validation.
Raquel Gil-Gouveia, António G Oliveira, Isabel Pavão Martins
https://pubmed.ncbi.nlm.nih.gov/21628438An international study to assess reliability of the Migraine Disability Assessment (MIDAS) score.
W F Stewart, R B Lipton, J Whyte...
https://pubmed.ncbi.nlm.nih.gov/10496257Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data.
David W Dodick, Stephen D Silberstein, Richard B Lipton...
https://pubmed.ncbi.nlm.nih.gov/31112399Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition.
Hans-Christoph Diener, Cristina Tassorelli, David W Dodick...
https://pubmed.ncbi.nlm.nih.gov/30806518OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial.
S K Aurora, D W Dodick, C C Turkel...
https://pubmed.ncbi.nlm.nih.gov/20647170Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults.
Cristina Tassorelli, Hans-Christoph Diener, David W Dodick...
https://pubmed.ncbi.nlm.nih.gov/29504482