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NCT04066023 · ClinicalTrials.gov registry record · Phase 2
Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
A Phase 2 study of Cluster Headache, sponsored by Zosano Pharma Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 12
- Study locations
NCT04066023 is a Phase 2 study of Cluster Headache that has completed, run by Zosano Pharma Corporation. The registered enrollment target is 42 participants, below the 555-participant average among 3 other Cluster Headache trials with a reported enrollment target (92% lower). The trial reports 12 study locations across 10 states.
The verdict
NCT04066023, a Phase 2 study of Cluster Headache, has completed, sponsored by Zosano Pharma Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 12
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 555-participant average among 3 other Cluster Headache trials with a reported enrollment target (92% lower). The listed sponsor is Zosano Pharma Corporation, which has 7 total studies on file at ClinicalTrials.gov.
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.
NCT04066023 reports 12 study locations spanning 10 distinct geographic areas - top geographies include California, Connecticut, Georgia.
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.
What interventions are being tested in trial NCT04066023?
The interventions under investigation include: Placebo (DRUG), C213 Microneedle System (DRUG).
Who is sponsoring clinical trial NCT04066023?
This trial is sponsored by Zosano Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.