Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Cluster Headache, sponsored by Zosano Pharma Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
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 |
What the finished NCT04066023 record still lists
NCT04066023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 555-participant average among 3 other Cluster Headache trials with a reported enrollment target (92% lower).
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 lists 12 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Cluster Headache
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
RECRUITING · Phase 2
-
The Will Erwin Headache Research Center - Cluster Headache Study
RECRUITING
-
Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02852213 · 42 participants · Phase 1
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
- NCT03136146 · 42 participants · Phase 2
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
- NCT03178149 · 42 participants · Phase 1
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- NCT03663530 · 42 participants · NA
Circadian Misalignment and Energy Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI