Title

A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    zucapsaicin ...
  • Study Participants

    60
This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).
Study Started
Jan 31
2002
Primary Completion
Jul 31
2003
Study Completion
Jul 31
2003
Last Update
Jun 10
2011
Estimate

Drug Civamide (Zucapsaicin)

Criteria

At least 2 year history of episodic cluster headache (meeting IHS criteria)
At least 2 previous episodes
Expected duration of cluster period is at least 6 weeks but not longer than 16 weeks
At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment
No Results Posted