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Civamide Nasal Solution for Cluster Headache

NCT01341548 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-04-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of intranasally administered civamide nasal solution in the prevention of cluster headaches during an episodic cluster headache period.

Conditions

  • Episodic Cluster Headache

Interventions

DRUG

Civamide nasal solution 0.01%

20ug/dose, BID for 7 days 0.1 ml to each nostril

Sponsors & Collaborators

  • Winston Laboratories

    lead INDUSTRY

Principal Investigators

  • Scott B Phillips, M.D. · Winston Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-11-30
Completion
2026-02-28
FDA Drug
Yes

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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 NCT01341548 on ClinicalTrials.gov