Civamide Nasal Solution for Cluster Headache

NCT01341548 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: WL-1001-02-06
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Nasal; Cluster Headache; Episodic Cluster; Headache; Phase 3; Civamide; TRPV-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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Subject has ≥2 year history of episodic cluster headache with at least 2 previous episodic cluster headache periods.
• Cluster Headaches must meet the following International Headache Society Diagnostic Criteria :
• Severe, unilateral, orbital, superorbital and/or temporal pain lasting 15 to 180 minutes untreated.
• Headache is associated with at least one of the following which have to be present on the side of the pain:
• Conjunctival injection
• Lacrimation
• Nasal Congestion
• Rhinorrhea
• Forehead and facial sweating
• Miosis
• Ptosis
• Eyelid edema or
• A sense of restlessness or agitation

You may not qualify if:

• Clinical, historical or previous laboratory evidence of significant cardiovascular, renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (not including cluster headaches), psychological, or other systemic disease that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
• Presence of a significant nasal disorder.
• Initiation of a medication, discontinuation of a medication or a change in the regimen of existing medication(s) or therapies for prophylaxis of cluster headaches in the 17 days prior to entering the Treatment Period (Study Day 1).
• Use of systemic steroids to treat the current cluster headache episode.
• Use of restricted medications/treatments within the given time period prior to the Treatment Period and throughout the study (Table 1 of Protocol)
• Subject has difficulty distinguishing his/her episodic cluster headache attacks from other types of headaches, such as tension type headaches.
• Presence of chronic paroxysmal hemicrania, transformed migraine, or analgesic rebound headaches.
• Females who are pregnant, breast-feeding, or planning to become pregnant during the study.
• Subject has a history of alcohol and/or drug abuse within 12 months prior to the Screening Visit..
• Subject has known hypersensitivity to or contraindication to the use of civamide, capsaicin, or to any excipient of the clinical formulation.
• Subject has participated in another investigational study or taken another investigational drug within the past 4 weeks.
• Subject has participated in prior efficacy studies of intranasal civamide: WL-1001-02-01, WL-1001-02-02, WL-1001-02-03 or WL-1001-02-05. (This does not include any subject who entered the screening period for study WL-1001-02-01, WL-1001-02-02, WL-1001-02-03 or WL-1001-02-05 but did not randomize to treatment).

Sponsors & Collaborators

• Winston Laboratories: lead

MeSH Terms

Conditions

Cluster Headache; Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological 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; scott@winstonlabs.com

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 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share