Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
Public ClinicalTrials.gov record NCT03557333. 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
Open-label Study of Safety and Tolerability of Chronic Intermittent Usage for 24 or 52 Weeks of Intranasal Dihydroergotamine Mesylate (DHE) Administered Using the I123 Precision Olfactory Delivery (POD®) Device [INP104, POD-DHE] in Patients With Migraine Headache
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study consists of a 4-week screening period, a 24-week treatment period for all participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a subset of at least 60 and up to 80 participants, and a 2-week post-treatment follow-up period.
Study identification
- NCT ID
- NCT03557333
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 360 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
- Jul 13, 2018 (Actual)
- Primary completion
- Mar 17, 2020 (Actual)
- Completion
- Mar 17, 2020 (Actual)
- Last update posted
- Mar 11, 2021
2018 – 2020
United States locations
- U.S. sites
- 36
- U.S. states
- 25
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest | Birmingham | Alabama | 35211 | — |
| Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203 | Birmingham | Alabama | 35235 | — |
| Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road | Chandler | Arizona | 85224 | — |
| Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191 | Phoenix | Arizona | 85020 | — |
| Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415 | Long Beach | California | 90806 | — |
| Excell Research, 3998 Vista Way | Oceanside | California | 92056 | — |
| Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200 | Colorado Springs | Colorado | 80909 | — |
| Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420 | Jacksonville | Florida | 32256 | — |
| Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100 | Orlando | Florida | 32801 | — |
| Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760 | Tampa | Florida | 33634 | — |
| ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200 | West Palm Beach | Florida | 33407 | — |
| Clinical Research of Central Florida, 500 East Central Avenue | Winter Haven | Florida | 33880 | — |
| Synexus - Atlanta, 6065 Roswell Road, Suite 820 | Atlanta | Georgia | 30328 | — |
| Cedar Crosse Research Center, 800 South Wells Street, Suite M-15 | Chicago | Illinois | 60607 | — |
| Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive | Evansville | Indiana | 47714 | — |
| Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor | Lexington | Kentucky | 40509 | — |
| Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513 | Marrero | Louisiana | 70072 | — |
| Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417 | Edina | Minnesota | 55435 | — |
| StudyMetrix Research, LLC., 3862 Mexico Road | City of Saint Peters | Missouri | 63303 | — |
| Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103 | St Louis | Missouri | 63141 | — |
| Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road | Omaha | Nebraska | 68144 | — |
| Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130 | Henderson | Nevada | 89052 | — |
| Hassman Research Institute, 175 Cross Keys Road, Suite 300B | Berlin | New Jersey | 08009 | — |
| Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO | Brooklyn | New York | 11229 | — |
| CNS Research Science, Inc., 80-15 164th Street | Jamaica | New York | 11432 | — |
| Aventiv Research, 99 North Brice Road, Suite 260 | Columbus | Ohio | 43213 | — |
| OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5 | Edmond | Oklahoma | 73034 | — |
| Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350 | Portland | Oregon | 97210 | — |
| Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4 | Smithfield | Pennsylvania | 15478 | — |
| Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2 | North Charleston | South Carolina | 29406 | — |
| MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109 | Chattanooga | Tennessee | 37421 | — |
| Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420 | Memphis | Tennessee | 38119 | — |
| FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300 | Austin | Texas | 78731 | — |
| Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220 | Plano | Texas | 75093 | — |
| Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B | Murray | Utah | 84123 | — |
| National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140 | Richmond | Virginia | 23294 | — |
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 NCT03557333, 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 Mar 11, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03557333 live on ClinicalTrials.gov.