At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓>1 year history of episodic or chronic cluster headache with onset before age 50, meeting ICHD-3 diagnostic criteria including ≥5 attacks of severe unilateral orbital/supraorbital/temporal pain lasting 45–180 min, with ipsilateral autonomic symptoms or restlessness, and frequency of 1 every other day to 8/day for >50% of active period
- ✓Cluster history in past 12 months: ≥1 cluster period averaging 2–6 headaches/day lasting ≥7 days
- ✓Able to distinguish cluster headaches from other headache types (migraine, tension-type)
- ✕Contraindications to triptans
- ✕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)
- ✕Previous M207/C213 exposure in a clinical trial
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Multi-Center, Parallel-Group Comparison of the Efficacy and Safety of the C213 (Zolmitriptan Microneedle System) to Placebo for the Acute Treatment of Cluster Headaches
In Brief
A Phase 3 clinical trial evaluating C213 Microneedle System and Placebo for Cluster Headache. Completed, enrolled 42 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.