Cluster Headache Cortivazol Injection (CHCI)
NCT00804895 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2012-11-27
Summary
the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.
Conditions
- Cluster Headache
Interventions
- DRUG
-
ALTIM, cortivazol injections
ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
- DRUG
-
PROAMP, subcutaneous serum physiological saline
Three injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Injection will be separated by two or three days each.
- DRUG
-
Verapamil
standard prophylactic treatment
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Dominique VALADE, MD · CHU Lariboisière, AP-HP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-12-31
- Primary Completion
- 2009-10-31
- Completion
- 2009-10-31
Countries
- France
Study Locations
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