Efficacy and safety of oral prednisone as add-on therapy in prophylactic treatment of episodic cluster headache: a randomized, placebo controlled parallel study.
- Conditions
- G44.0Cluster headache syndrome
- Registration Number
- DRKS00004716
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 118
Male and female patients between18 and 65 year of age, of legal competence, with sufficient proficiency of written and spoken German. Willing and capable to attend regular follow-up.
Episodic cluster headache according to the IHS-criteria;patient has had at least one previous attack before, average duration of previous cluster episodes at least one month untreated, expected duration of cluster period after randomization should be at least one month after initiation of therapy;
previous cluster episodes should be longer than one month away; at least second cluster episode during life-time. Beginning of current bout of Clster headache less than 30 days ago. Last bout more than 30 days ago.
No other prophylactic drugs than the study medication (prednisone) and verapamil within 30 days before inclusion into study.
Pregnancy and nursing. Other severe illnesss,
contraindication against prednison or verapamil; chronic cluster headache, Addiction to alcohol or other drugs, Diabetes mellitus, cardiac arrhythmia, osteoporosis, missing consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of cluster attacks within the first week of treatment with prednisone compared to a placebo, as documented in the headache diary.
- Secondary Outcome Measures
Name Time Method 1. Number of cluster attacks from day 1 to day 28 of study participation.<br>2. Number of cluster attacks from day 7 to day 28 of treatment.<br>3. Episode abortion ( yes/no), defined as no further attacks in the last 3 days before check-up on day 7 or day 28<br>4. Number of intakes of acute medication until day 7 and until day 28.<br>5. Therapy response (reduction rate of total number of attacks >50%, as compared to day -3 till day 0, measured after 7 and 28 days) defined as number of attacks/day<br>6. Trigemino-autonomous symptoms (yes/no after 7 and 28 days)<br>