At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Corabotase (biological), Placebo (other), Corabotase dose A (biological), Corabotase dose B (biological)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- Corabotase — biological: Lyophilised powder · Placebo — other: Excipients without active substance, Lyophilised powder · Corabotase dose A — biological: Lyophilised powder · Corabotase dose B — biological: Lyophilised powder
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 670
- Started
- 2024-10-10
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for episodic migraine
- • Phase2 - 670 participants
- • A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with episodic migraine
Where?
- • Exeter - Royal Devon And Exeter Hospital - Neurology
- • Hull - Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary
- • Liverpool - Walton Centre For Neurology And Neurosurgery
- • London - King's College Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. Corabotase (also known as IPN10200) is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: * The safety and efficacy of injecting Corabotase directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of Corabotase to inject at each point, * The total amount (dose) of Corabotase that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks.
More detail
The study will consist of 3 periods: 1. A 'screening period' to assess whether the participant can take part in the study. 2. Step 1 is divided in two cohorts. The study will assess sequentially the safety of two doses of Corabotase, a lower dose in the cohort 1 and a higher dose in cohort 2. Participants will be administered with the study drug or placebo. The treatment is injected in muscles of the head, face and neck. The safety of participants is monitored throughout the 36 weeks at each cohort. 3. Step 2: In this step, new eligible participants will be divided into two groups based on their diagnosis (EM or CM). These groups will then be randomly assigned to one of three intervention groups: Dose A, Dose B, or a placebo. The intervention will be given in a series of injections in muscles of the head, face and neck. Participants will be monitored for both efficacy and safety until they complete the Week 36 visit (the end of study).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Male or female ≥18 to 80 years of age at the time of signing the agreement to take part;
- ✓Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;
- ✓Diagnosis of migraine at ≤50 years of age;
- ✓Participant with a history of use of at least one preventive treatment for migraine.
Who cannot take part
- ✗Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);
- ✗Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of...
- ✗Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing items 3, 4, or 5 on the...
- ✗Participants presenting with a swallowing disorder of any origin which might be exacerbated by botulinum toxin...
- ✗\- Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a...
See the full criteria
Where Is This Study? (4 UK sites)
Royal Devon And Exeter Hospital - Neurology
Exeter, United Kingdom
Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary
Hull, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Walton Centre For Neurology And Neurosurgery
Liverpool, United Kingdom
King's College Hospital
London, United Kingdom
