The impact of a 12-week open-label placebo treatment on headache days in episodic and chronic migraine: A randomized controlled trial
- Conditions
- G43.9Migraine, unspecified
- Registration Number
- DRKS00021259
- Lead Sponsor
- niversitätsklinikum EssenKlinik für Neurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Age =18 years, history of episodic or chronic migraine (patient self-report and diagnosed by a specialist in neurology according to the International Classification of Headache Disorders (Olesen 2018)) =12 months prior to screening, migraine frequency =4 days per month on average across 3 months prior to screening, consent and fluent German language skills.
Any substance or alcohol abuse, major depression, schizophrenia, suicidality, hypersensitivity or allergy to any ingredient of the placebo pills, participation in another study using investigational drugs within the last 3 months prior to inclusion, and any acute or chronic pain condition apart from migraine. Patients volunteering to attend the optional MRI session must not suffer from claustrophobia or have any implants or devices unsuitable for MRI.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of headache days in 4 weeks from baseline to visit 3
- Secondary Outcome Measures
Name Time Method Change in migraine days in 4 weeks from baseline to visit 3, in mean pain intensity (NRS), days of use of acute medication in 4 weeks, disability (Pain Disability Index, Headache Impact Test), global impression of change (PGIC), quality of life (Short Form Health Survey), count of patients with 50% reduction in primary outcomes (responder rate), safety and tolerability (General Assessment of Side Effects). Explorative outcomes comprise potential predictors.