Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of … (NCT04066023) | Clinical Trial Compass
CompletedPhase 2/3
Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
United States42 participantsStarted 2019-10-03
Plain-language summary
This is a double-blind, placebo-controlled study. Subjects who meet the entry criteria will be randomized o receive one of three blinded treatments \[C213 1.9 mg patch and placebo patch; C213 3.8 mg (1.9 mg x 2 patches), two placebo patches\] on Day 1 and will have up to 48 weeks to confirm and treat a cluster headache. Subjects will self-administer the patches and respond to questions in the electronic diary (eDiary) until 1-hour post treatment administration.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Able to provide written informed consent
✓. Women or men 18 to 65 years of age
✓. Greater than 1-year history of episodic or chronic cluster headache with onset prior to 50 years of age. Diagnosis must comply with ICHD-3 (International Headache Society (IHS) diagnostic criteria). Diagnostic criteria must include a history of at least 5 attacks not attributed to any other disorder that include all of the following criteria:
✓. Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 45-180 minutes (average, when untreated)
✓. Either or both of the following:
✓. At least one of the following symptoms or signs, ipsilateral to the pain:
✓. Conjunctival injection and/or lacrimation
✓. Nasal congestion and/or rhinorrhea
Exclusion criteria
✕. Contraindications to triptans
✕. Use of any prohibited concomitant medications within 30 days of screening
✕. History of hemiplegic migraine or migraine with brainstem aura
✕. Participation in another investigational trial within 30 days or 5 half-lives of investigational product (whichever is longer).
What they're measuring
1
Percentage of Subjects Who Achieve Pain Relief
Timeframe: 15 minutes
2
Percentage of Subjects Who Achieve Sustained Pain Relief
✕. Subject has other significant pain problems that might confound the study assessments in the opinion of the investigator
✕. Diagnosis of any malignant disease (other than adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin) within the 5 years prior to screening
✕. History of unstable psychiatric illness requiring medication or hospitalization in the 12 months prior to study initiation