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Clinical Trials in the USA / NCT06047457
Active, not recruiting Phase 3

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults

NCT06047457 · tracked via the Priya Life Science USA tracker
Sponsor
Ipsen
Phase
Phase 3
Started
2023-09-29
Last updated
2026-09-04

Condition(s) studied

Episodic Migraine

Investigational drug(s) / intervention(s)

Botulinum toxin type ABotulinum toxin type APlaceboBotulinum toxin type ABotulinum toxin type A

Botulinum toxin type A: Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.

Botulinum toxin type A: Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.

Placebo: "0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.

Botulinum toxin type A: Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.

Botulinum toxin type A: Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.

Study summary

The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine.

A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound.

Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches.

Migraines are caused by a series of events which cause the brain to get stimulated / activated, which results in the release of chemicals that cause pain.

Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers.

The study will consist of 3 periods:

1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit.
2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders.

The injections will contain either a dose "A" or a dose ''B'' of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied).

Participants will make 4 visits to the clinic in person and have 4 remote (online) visits.
3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B").

There will be 3 in person visits and 4 remote visits.

Participants will need to complete an e-diary and questionnaires throughout the study.

Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.

The total study duration for a participant will be up to 60 weeks (approx. 14 months).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria : * Must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation. * Participant has a diagnosis for more than 12 months, prior to screening visit, of migraine with aura or migraine without aura according to the International Classification of Headache Disorders definition and diagnostic criteria * Migraine onset occurred when participant was \<50 years of age. * Has baseline number of monthly headache days (MHD) of \<15 and baseline number of monthly migraine days (MMD) of ≥6, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation). * Has baseline number of valid diary days ≥22 days collected during the 4 weeks nearest to randomisation on Day 1. * Participant must have previously used, or is currently using, preventive treatment for migraine (pharmacological) (i.e. non-naïve) prior to start of screening eDiary Exclusion Criteria : * History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache. * Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted. * Use of any of the following medications in the specified timeframe prior to start of the screening daily headache eDiary: a. Within 24 weeks * i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks) b. Within 12 weeks * i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted, but limited to no more than 6 days per month (i.e. 6 days per each 4-week period with gepant intake)) * ii. Cannabinol or other types of cannabinoids c. Within 4 weeks * i. Anaesthetic or steroid injection in any region targeted for injection with study intervention * ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation) * iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) iv. Use of opioids or barbiturates for more than 2 days/month. Note: participants are permitted to take one concomitant migraine preventative treatment (not listed above); however, the dose of this medication should be stable for ≥3 months before start of the screening eDiary. • Known history of treatment failure to more than four medications prescribed for the prevention of migraine (two of which have different mechanisms of action) or known history of treatment failure to botulinum toxin prescribed for the prevention of migraine

Primary outcome measure(s)

Trial sites (105)

FacilityCityRegionStatus
Central Research Associates Birmingham Alabama
CCT Research Phoenix Arizona
HonorHealth Neurology Scottsdale Arizona
Hope Clinical Research, LLC Canoga Park California
Axiom Research LLC Colton California
Fullerton Neurological Center Fullerton California
Neurology Center of North Orange County Fullerton California
SDS Clinical Trials Orange California
Alliance Clinical San Diego (Acclaim Clinical Research) San Diego California
The Los Angeles Headache Center Savannah California
Yale University School of Medicine East Hartford Connecticut
Hasbani Neurology New Haven Connecticut
New England Institute for Neurology and Headache (NEINH)/Medical Practice Stamford Connecticut
Visionary Investigators Network (VIN) Aventura Florida
Velocity Clinical Research - Hallandale Beach Hallandale Florida
AGA Clinical Trials Hialeah Florida
Infinity Clinical Research, LLC Hollywood Florida
Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC) Jacksonville Florida
840042 Miami Florida
Quantum Clinical Trials Miami Beach Florida
Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry) Orlando Florida
Guardian Angel Research Center Tampa Florida
Boston Clinical Trials Inc Winter Park Florida
Conquest Research Winter Park Florida
Cedar Crosse Research Center Chicago Illinois
Chicago Headache Center & Research Institute Chicago Illinois
Robbins Headache Clinic Riverwoods Illinois
MD Fort Wayne Neurological Center Fort Wayne Indiana
Comprehensive Neurology Services Frederick Maryland
Boston Clinical Trials Inc Boston Massachusetts
Beth Israel Deaconess Medical Center - Arnold Pain Management Brookline Massachusetts
Neurology Center of NE,PC - Neurology Foxborough Massachusetts
Lone Star Neurology, Westborough Massachusetts
New England Regional Headache Center, Inc. Worcester Massachusetts
Quest Research Institute Farmington Hills Michigan
Minneapolis Clinic of Neurology Burnsville Minnesota
Clinical Research Professionals Chesterfield Missouri
M3 Wake Research - Las Vegas Wellness Way Las Vegas Nevada
Alliance Clinical Las Vegas (Excel Clinical Research) Las Vegas Nevada
SPRI Clinical Trials, LLC Brooklyn New York

+ 65 more sites — see the full list on the official registry below.

More Ipsen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06047457 on ClinicalTrials.gov ↗ ← All trials in the USA