Episodic Cluster HeadachePhase 3ECHNCT01341548
Civamide Nasal Solution for Cluster Headache
A Phase 3 study testing Civamide nasal solution 0.01% in people with Episodic Cluster Headache, run by Winston Laboratories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episodic Cluster Headache
- What is being tested?
- Civamide nasal solution 0.01%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase III, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group, Multicenter Evaluation of Civamide Nasal Solution 0.01% in the Prevention of Cluster Headaches During an Episodic Cluster Headache Period
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.
Read the detailed description
This is a double-blind, randomized, vehicle-controlled, parallel-group, multi-center, phase III efficacy and safety study of civamide nasal solution 0.01% in the prevention of cluster headaches during an episodic cluster headache period. Approximately 180 subjects (about 90 per treatment group),will be enrolled and randomized to double-blind treatment with either civamide nasal solution 0.01% or vehicle solution at approximately 50 study sites with about 2-5 subjects randomized per enrolling site.
This study consists of four periods beginning with a Screening Period, lasting for a minimum of 1 day to a maximum of 12 months, during which a subject previously diagnosed with episodic cluster headaches is not experiencing cluster headaches and is awaiting the onset of their next episodic cluster headache period and subsequent enrollment. The Screening Period is followed by a 31-day study, consisting of a 3-day Baseline Period which may begin with the onset of an episodic cluster headache period and ends on the day prior to initiating treatment (Day -1). Subjects return for Visit 2 (Day 1, Pre-Dose) and the Treatment Period begins, consisting of seven (7) days of double-blind treatment. The Treatment Period is immediately followed by a twenty-one (21) day Post-Treatment Observation Period.
- Conditions
- Episodic Cluster Headache
- Being tested
- Civamide nasal solution 0.01%
- Keywords
- Nasal, Cluster Headache, Episodic Cluster, Headache, Phase 3, Civamide, TRPV-1 Receptor
- Medical subject headings
- Cluster Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Civamide nasal solution 0.01%Drug
20ug/dose, BID for 7 days 0.1 ml to each nostril
| Study group | Role | What they receive |
|---|---|---|
| Civamide Nasal Solution 0.01% | Active comparator | Not described Receives: Drug: Civamide nasal solution 0.01% |
| Vehicle Solution | Placebo comparator | Not described Receives: Drug: Civamide nasal solution 0.01% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Weeks 1 - 3 and to Individual Weeks 1, 2, and 3 for the Post-Treatment Observation Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startNov 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott B Phillips, M.D., Study director, Winston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341548
- Sponsor's protocol ID
- WL-1001-02-06
- Acronym
- ECH
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2011
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group, Multicenter Evaluation of Civamide Nasal Solution 0.01% in the Prevention of Cluster Headaches During an Episodic Cluster Headache Period
- ClinicalTrials.gov ID
- NCT01341548
- Acronym / sponsor ID
- ECH / WL-1001-02-06
- Conditions
- Episodic Cluster Headache
- Keywords
- Nasal, Cluster Headache, Episodic Cluster, Headache, Phase 3, Civamide, TRPV-1 Receptor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a double-blind, randomized, vehicle-controlled, parallel-group, multi-center, phase III efficacy and safety study of civamide nasal solution 0.01% in the prevention of cluster headaches during an episodic cluster headache period. Approximately 180 subjects (about 90 per treatment group),will be enrolled and randomized to double-blind treatment with either civamide nasal solution 0.01% or vehicle solution at approximately 50 study sites with about 2-5 subjects randomized per enrolling site.
This study consists of four periods beginning with a Screening Period, lasting for a minimum of 1 day to a maximum of 12 months, during which a subject previously diagnosed with episodic cluster headaches is not experiencing cluster headaches and is awaiting the onset of their next episodic cluster headache period and subsequent enrollment. The Screening Period is followed by a 31-day study, consisting of a 3-day Baseline Period which may begin with the onset of an episodic cluster headache period and ends on the day prior to initiating treatment (Day -1). Subjects return for Visit 2 (Day 1, Pre-Dose) and the Treatment Period begins, consisting of seven (7) days of double-blind treatment. The Treatment Period is immediately followed by a twenty-one (21) day Post-Treatment Observation Period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Civamide Nasal Solution 0.01% | Active comparator | Drug: Civamide nasal solution 0.01% |
| Vehicle Solution | Placebo comparator | Drug: Civamide nasal solution 0.01% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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 :
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Civamide nasal solution 0.01%20ug/dose, BID for 7 days 0.1 ml to each nostril | Drug | Civamide Nasal Solution 0.01%, Vehicle Solution |
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
Time frame: Weeks 1 - 3 of the Post-Treatment Observation Period
3 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: Weeks 1 - 3 and to Individual Weeks 1, 2, and 3 for the Post-Treatment Observation Period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott B Phillips, M.D. study director
Winston Laboratories
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Civamide nasal solution 0.01% in people with Episodic Cluster Headache, run by Winston Laboratories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi B Fezatte, BS (847-362-8200, heidi@winstonlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Weeks 1 - 3 of the Post-Treatment Observation Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.