A Phase 3 interventional study of Civamide nasal solution 0.01% in Episodic Cluster Headache, sponsored by Winston Laboratories. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-23.
Sponsored by Winston Laboratories · Phase 3, Interventional, and Prevention
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.
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 180 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Winston Laboratories is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cluster Headaches must meet the following International Headache Society Diagnostic Criteria :
Headache is associated with at least one of the following which have to be present on the side of the pain:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Civamide nasal solution 0.01%
Drug: Civamide nasal solution 0.01%
20ug/dose, BID for 7 days 0.1 ml to each nostril
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2023; primary completion for Nov 2025, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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