Intranasal Civamide for Episodic Cluster Headache

Winston Laboratories

Status and phase: Completed; Phase 3

Conditions: Episodic Cluster Headache

Treatments: Drug: Civamide (Zucapsaicin); Drug: Sodium Chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00069082

WL-1001-02-05

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).

Enrollment: 2 patients

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 24 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: Quadruple Blind

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2 participants in 2 patient groups, including a placebo group

Civamide

Active Comparator group

Description:

Nasal Solution 0.01%

Treatment:

Drug: Civamide (Zucapsaicin)

Placebo

Placebo Comparator group

Description:

Placebo nasal solution with sodium chloride 10%

Treatment:

Drug: Sodium Chloride