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Episodic Cluster Headache | Civamide Nasal Solution for Cluster Headache

Episodic Cluster Headache research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 - The current episodic cluster headache period is expected to last at least 5 weeks but no more than 24 weeks from the time of entry into the Baseline Period (Day -3), based on the average duration of the subject's usual episodic cluster headache period. - At least one cluster headache (but no more than 8) daily on each of the three days of the Baseline Period (Days -3, -2, -1) immediately preceding Study Day 1. - The subject is in generally good health, other than history of episodic cluster headache. - The subject agrees not to begin any new concurrent medications or restricted medications during their participation in study. - All females of childbearing potential must have a negative urine and/or serum pregnancy test prior to entry into the Treatment Period. - Females of childbearing potential agree to use an approved form of birth control or to abstain from sexual activity during the study. - Subject can read and write in the local language and can be expected to reliably follow study procedures. Exclusion Criteria: - 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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Episodic Cluster Headache

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Civamide nasal solution 0.01%20ug/dose, BID for 7 days 0.1 ml to each nostril

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Civamide Nasal Solution 0.01%

Vehicle Solution

Study Status

Not yet recruiting

Start Date: November 2019

Completed Date: February 2022

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 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

Secondary Outcome: 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

Study sponsors, principal investigator, and references

Principal Investigator: Scott B Phillips, M.D.

Lead Sponsor: Winston Laboratories

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01341548

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