Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
Public ClinicalTrials.gov record NCT04066023. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04066023
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2, 2019
- Primary completion
- Apr 13, 2021
- Completion
- Apr 13, 2021
- Last update posted
- Jun 13, 2022
2019 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Keck Medicine of USC | Los Angeles | California | 90033 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | — |
| KI Health Partners LLC DBA New England Institute for Clinical Research | Stamford | Connecticut | 06905 | — |
| Atlanta Headache Specialists | Atlanta | Georgia | 30328 | — |
| New England Regional Headache Center, Inc. | Worcester | Massachusetts | 01605 | — |
| Nevada Headache Institute | Las Vegas | Nevada | 89113 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Dent Neuro Institute, Buffalo | Amherst | New York | 14226 | — |
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | — |
| University of Texas Southwestern Medical Center- Neurology Clinic | Dallas | Texas | 75390 | — |
| Medstar Georgetown University Hospital at McLean | McLean | Virginia | 22101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04066023, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 13, 2022 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04066023 live on ClinicalTrials.gov.