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Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
NCT04066023 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG C213 Microneedle System
Study Locations (12)
California
- Keck Medicine of USC — Los Angeles
- Stanford University — Palo Alto
- California Medical Clinic for Headache — Santa Monica
Connecticut
- KI Health Partners LLC DBA New England Institute for Clinical Research — Stamford
Georgia
- Atlanta Headache Specialists — Atlanta
Massachusetts
- New England Regional Headache Center, Inc. — Worcester
Nevada
- Nevada Headache Institute — Las Vegas
New Hampshire
- Dartmouth Hitchcock Medical Center — Lebanon
New York
- Dent Neuro Institute, Buffalo — Amherst
Pennsylvania
- Jefferson Headache Center — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2021-04-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04066023
The ClinicalTrials.gov registry entry for NCT04066023 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zosano Pharma Corporation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cluster Headache appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04066023 reports 12 study locations spanning 10 distinct geographic areas — top geographies include California, Connecticut, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04066023 about?
NCT04066023 is a clinical study titled "Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches". 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 trea...
What is the current status of trial NCT04066023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-10-03. Estimated completion is 2021-04-14.
What conditions does trial NCT04066023 study?
This clinical trial studies the following conditions: Cluster Headache. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04066023?
The interventions under investigation include: Placebo (DRUG), C213 Microneedle System (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04066023?
This trial is sponsored by Zosano Pharma Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04066023 being conducted?
This trial has 12 study locations across California, Connecticut, Georgia, Massachusetts, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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