Cluster Headache Cortivazol Injection (CHCI)

NCT00804895 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2012-11-27

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00804895 on ClinicalTrials.gov