Efficacy and safety of cortison for decreasing the frequency of cluster headache: a randomized study with placebo as comperator. All patients will receive as basic therapy Verapamil additionally to cortison.
Phase 1
- Conditions
- Episodic Cluster Headache (ECH)MedDRA version: 18.0Level: LLTClassification code 10009698Term: Cluster headachesSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-006204-13-DE
- Lead Sponsor
- niversity of Duisburg-Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
Episodic cluster headache according to the IHS-criteria; previous duration of typical cluster period; previous cluster episodes should be longer than one month past;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
pregnancy/nursing; additional physical or psychological illnesses; contraindications for verapamil or prednisone treatment; chronic cluster headache; drug/alcohol abuse; diabetes mellitus; cardiac arrhythmia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method