NCT00069082

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

September 15, 2003

Last Update Submit

June 8, 2011

Conditions

Episodic Cluster Headache

Keywords

HeadacheClusterECEpisodic Cluster

Study Arms (2)

Civamide

ACTIVE COMPARATOR

Nasal Solution 0.01%

Drug: Civamide (Zucapsaicin)

Placebo

PLACEBO COMPARATOR

Placebo nasal solution with sodium chloride 10%

Drug: Sodium Chloride

Interventions

Civamide (Zucapsaicin)DRUG

Nasal Solution 0.01%

Civamide
Sodium ChlorideDRUG

Nasal Solution 10%

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

San Francisco Clinical Research Center

San Francisco, California, United States

Location

California Medical Clinic for Headache

Santa Monica, California, United States

Location

Colorado Neurology and Headache Clinic

Denver, Colorado, 80218, United States

Location

Diamond Headache Clinic

Chicago, Illinois, United States

Location

New York Headache Center

New York, New York, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

MeSH Terms

Conditions

Cluster HeadacheHeadache

Interventions

zucapsaicinSodium Chloride

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Scott B Phillips, MD

    Winston Laboratories

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2003

First Posted

September 16, 2003

Study Start

August 1, 2003

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

US(6)