Trials Sponsors Conditions Drugs Pricing

Conditions

Episodic Cluster Headache

Keywords

NasalCluster HeadacheEpisodic ClusterHeadachePhase 3CivamideTRPV-1 Receptor

Outcome Measures

Primary Outcomes (1)

The Percent Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 of the Post-Treatment Observation Period for the Modified Intent-to-Treat Population
Weeks 1 - 3 of the Post-Treatment Observation Period

Secondary Outcomes (3)

The Percent Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 of the Post-Treatment Observation Period for the Intent-to-Treat and Per Protocol Populations
Weeks 1 - 3 of the Post-Treatment Observation Period
The Percent Change in the Number of Cluster Headaches per Week from Baseline to Individual Weeks 1, 2, and 3 of the Post-Treatment Observation Period for the Modified Intent-to-Treat and the Per Protocol Populations
Individual Weeks 1, 2 and 3 of the Post-Treatment Observation Period
The Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 and to Individual Weeks 1, 2, and 3 for the Post-Treatment Observation Period for the Modified Intent-to-Treat and the Per Protocol Populations
Weeks 1 - 3 and to Individual Weeks 1, 2, and 3 for the Post-Treatment Observation Period

Study Arms (2)

Civamide Nasal Solution 0.01%

ACTIVE COMPARATOR

Drug: Civamide nasal solution 0.01%

Vehicle Solution

PLACEBO COMPARATOR

Drug: Civamide nasal solution 0.01%

Interventions

Civamide nasal solution 0.01%Drug

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

Civamide Nasal Solution 0.01%Vehicle Solution

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written IRB-approved informed consent has been obtained and signed, within 12 months of entering into the Baseline Period (Day -3).
Male or female 18 years or older.

Sponsors & Collaborators

Winston Laboratories
Industrylead

MeSH Terms

Conditions

Cluster HeadacheHeadache

Condition Hierarchy (Ancestors)

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

Study Officials

Scott B Phillips, M.D.
Winston Laboratories
STUDY DIRECTOR

Central Study Contacts

Heidi B Fezatte, BS

CONTACT

847-362-8200 heidi@winstonlabs.com

Scott B Phillips, MD

CONTACT

847-362-8200

Study Design

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

Study Record Dates

First Submitted

April 22, 2011

First Posted

April 25, 2011

Study Start

November 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

November 2025

Civamide Nasal Solution for Cluster Headache

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Civamide Nasal Solution 0.01%

Vehicle Solution

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Civamide Nasal Solution 0.01%

Vehicle Solution

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record