Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)

Completed · Phase 3

Conditions studied: Migraine Headache

In brief

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.

Key facts

Study ID

NCT03557333

Run by

Impel Pharmaceuticals

People needed

360

Starts

2018-07-13

Expected to finish

2020-03-17

Last updated by the study team

2021-03-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of migraine with or without aura, with at least 2 attacks per month for the previous 6 months.
• Participants must be in good general health, with no significant medical history (excluding migraine).
• Participants must have the ability and willingness to attend the necessary visits at the study center.
• Participants must be able to provide the written informed consent prior to entry into the study.
• Women of childbearing potential must agree to use adequate contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose fo the study drug.
• Male participants and their partners must agree to use effective contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose of the study drug. Male participants should also refrain from sperm donation for 30 days after study completion.

You may not qualify if…

• Subjects with trigeminal autonomic cephalalgias (including cluster headache, hemicrania syndromes and short-lasting unilateral, neuralgiform headache attacks with conjunctival injection and tearing), hemiplegic migraine, or migraine with brainstem aura (previously referred to as basilar migraines).
• Subjects with chronic migraines, medication overuse headache or other chronic headache syndromes.
• Subjects with ischemic heart disease or subjects with clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina.
• Subjects with significant risk factors for coronary artery disease (CAD) including current use of nicotine-containing products, medical history of diabetes, uncontrolled hypertension (high blood pressure), known peripheral arterial disease, Raynaud's phenomenon, sepsis or vascular surgery (within 3 months prior to study start), or severely impaired hepatic or renal (kidney) function.
• Subjects with recurrent sinusitis or epistaxis.
• Subjects with a history or presence of alcoholism or drug abuse within 2 years prior to first study drug administration.
• Women who are pregnant, or planning to get pregnant, or who are lactating while participating in the study.
• Use of any medications prohibited by protocol.
• Use of >12 days per month of triptan or ergot-based medication in the 2 months prior to screening.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203 — Birmingham, Alabama, United States
• Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road — Chandler, Arizona, United States
• Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191 — Phoenix, Arizona, United States
• Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415 — Long Beach, California, United States
• Excell Research, 3998 Vista Way — Oceanside, California, United States
• Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200 — Colorado Springs, Colorado, United States
• Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420 — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100 — Orlando, Florida, United States
• Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760 — Tampa, Florida, United States
• ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200 — West Palm Beach, Florida, United States
• Clinical Research of Central Florida, 500 East Central Avenue — Winter Haven, Florida, United States
• Synexus - Atlanta, 6065 Roswell Road, Suite 820 — Atlanta, Georgia, United States
• Cedar Crosse Research Center, 800 South Wells Street, Suite M-15 — Chicago, Illinois, United States
• Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive — Evansville, Indiana, United States
• Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor — Lexington, Kentucky, United States
• Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513 — Marrero, Louisiana, United States
• Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417 — Edina, Minnesota, United States
• StudyMetrix Research, LLC., 3862 Mexico Road — City of Saint Peters, Missouri, United States
• Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103 — St Louis, Missouri, United States
• Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road — Omaha, Nebraska, United States
• Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130 — Henderson, Nevada, United States
• Hassman Research Institute, 175 Cross Keys Road, Suite 300B — Berlin, New Jersey, United States
• Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO — Brooklyn, New York, United States
• CNS Research Science, Inc., 80-15 164th Street — Jamaica, New York, United States

Full record on ClinicalTrials.gov

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