search
Back to results

Intranasal Civamide for Episodic Cluster Headache

Primary Purpose

Episodic Cluster Headache

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Civamide (Zucapsaicin)
Sodium Chloride
Sponsored by
Winston Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Cluster Headache focused on measuring Headache, Cluster, EC, Episodic Cluster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco Clinical Research Center
  • California Medical Clinic for Headache
  • Colorado Neurology and Headache Clinic
  • Diamond Headache Clinic
  • New York Headache Center
  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Civamide

Placebo

Arm Description

Nasal Solution 0.01%

Placebo nasal solution with sodium chloride 10%

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 15, 2003
Last Updated
June 8, 2011
Sponsor
Winston Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT00069082
Brief Title
Intranasal Civamide for Episodic Cluster Headache
Official Title
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Winston Laboratories

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Cluster Headache
Keywords
Headache, Cluster, EC, Episodic Cluster

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Civamide
Arm Type
Active Comparator
Arm Description
Nasal Solution 0.01%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo nasal solution with sodium chloride 10%
Intervention Type
Drug
Intervention Name(s)
Civamide (Zucapsaicin)
Intervention Description
Nasal Solution 0.01%
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride
Intervention Description
Nasal Solution 10%

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott B Phillips, MD
Organizational Affiliation
Winston Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Colorado Neurology and Headache Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
New York Headache Center
City
New York
State/Province
New York
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intranasal Civamide for Episodic Cluster Headache

We'll reach out to this number within 24 hrs