A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

Winston Laboratories

Status and phase: Completed; Phase 3

Conditions: Episodic Cluster Headache

Treatments: Drug: Civamide (Zucapsaicin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00033839

WL-1001-02-02

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind