Episodic Cluster HeadachePhase 3NCT00069082
Intranasal Civamide for Episodic Cluster Headache
A Phase 3 study testing Civamide (Zucapsaicin) and Sodium Chloride in people with Episodic Cluster Headache, run by Winston Laboratories at 6 sites in United States.
Trial 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). 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 (Zucapsaicin) and Sodium Chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2003to Jan 2004
- 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
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Diamond Headache Clinic
Chicago, Illinois
Cleveland Clinic Foundation
Cleveland, Ohio
Colorado Neurology and Headache Clinic
Denver, Colorado, 80218
New York Headache Center
New York, New York
San Francisco Clinical Research Center
San Francisco, California
California Medical Clinic for Headache
Santa Monica, California
About this study
Official title: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache
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).
- Conditions
- Episodic Cluster Headache
- Being tested
- Civamide (Zucapsaicin), Sodium Chloride
- Keywords
- Headache, Cluster, EC, Episodic Cluster
- 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 (Zucapsaicin)Drug
Nasal Solution 0.01%
Sodium ChlorideDrug
Nasal Solution 10%
| Study group | Role | What they receive |
|---|---|---|
| Civamide | Active comparator | Nasal Solution 0.01% Receives: Drug: Civamide (Zucapsaicin) |
| Placebo | Placebo comparator | Placebo nasal solution with sodium chloride 10% Receives: Drug: Sodium Chloride |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2003 (estimated)
- Study startAug 2003
- Primary completionJan 2004
- Study completionJan 2004
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott B Phillips, MD, Study director, Winston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069082
- Sponsor's protocol ID
- WL-1001-02-05
- Status last verified
- Jun 2011
- First submitted
- 15 Sep 2003
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache
- ClinicalTrials.gov ID
- NCT00069082
- Acronym / sponsor ID
- WL-1001-02-05
- Conditions
- Episodic Cluster Headache
- Keywords
- Headache, Cluster, EC, Episodic Cluster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 16 Sep 2003 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Civamide | Active comparator | Drug: Civamide (Zucapsaicin)Nasal Solution 0.01% |
| Placebo | Placebo comparator | Drug: Sodium ChloridePlacebo nasal solution with sodium chloride 10% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 (Zucapsaicin)Nasal Solution 0.01% | Drug | Civamide |
| Sodium ChlorideNasal Solution 10% | Drug | Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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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, MD study director
Winston Laboratories
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Civamide (Zucapsaicin) and Sodium Chloride in people with Episodic Cluster Headache, run by Winston Laboratories at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 10 Jun 2011.