Intranasal Civamide for 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00069082

Enrollment

Registered

2003-09-16

Start date

2003-08-31

Completion date

2004-01-31

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episodic Cluster Headache

Keywords

Headache, Cluster, EC, Episodic Cluster

Brief summary

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).

Interventions

DRUGCivamide (Zucapsaicin)

Nasal Solution 0.01%

DRUGSodium Chloride

Nasal Solution 10%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026