- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00530517
A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack
November 8, 2022 updated by: Zogenix, Inc.
A Multi-Center, Open-Label, Single-dose, Single-Arm Study to Evaluate the Usability of Subcutaneously Administered Sumatriptan Delivered Via the Intraject® System in Adult Patients During Acute Migraine Attack
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan to be used by patients to treat acute migraine treatment.
Study participation will last one month and include 2 doctor visits and 2-4 phone calls.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will evaluate how patients will interact with the needle-free Intraject system during actual self-administration to the abdomen or thigh for treatment of migraine headache while outside the clinic.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60614
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-
Missouri
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Saint Louis, Missouri, United States, 63141
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Springfield, Missouri, United States, 65807
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Tennessee
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Nashville, Tennessee, United States, 37203
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a diagnosis of migraine with an average of ≥2 to ≤6 attacks/month
- Female subjects of child-bearing potential must agree to use acceptable birth control
- Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection
- Fluent in the spoken and written English language
- Provide written informed consent to participate in the study and be willing to comply with the study procedures
- Access to a telephone for call center interactions
Exclusion Criteria:
- A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease
- Other significant underlying cardiovascular diseases including uncontrolled hypertension
- Hemiplegic or basilar migraine
- A history or diagnosis of severe hepatic or renal impairment
- A history of epilepsy or seizure or other serious neurologic condition
- A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs
- A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
- Tattoos in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation
- Birthmark or other significant skin discoloration in the thigh or abdominal area large enough to restrict injection site selection and/or evaluation
- Pregnancy or breast-feeding
- Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
Time Frame: 30 Days
|
30 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Brandes, MD, Nashville Neuroscience Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 13, 2007
First Submitted That Met QC Criteria
September 13, 2007
First Posted (Estimate)
September 17, 2007
Study Record Updates
Last Update Posted (Actual)
November 10, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Headache
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Vasoconstrictor Agents
- Sumatriptan
Other Study ID Numbers
- ZX001-0701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
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Clinical Trials on Intraject Sumatriptan
-
Zogenix, Inc.CompletedPharmacokinetics | BioequivalenceUnited States
-
GlaxoSmithKlineCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Upsher-Smith LaboratoriesCompletedMigraine HeadachesUnited States
-
Organon and CoCompleted
-
Sorrento Therapeutics, Inc.Kimberly-Clark CorporationCompletedMigraine DisordersUnited States
-
Cambridge University Hospitals NHS Foundation TrustUnknown
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedMigraine With or Without Aura
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedMigraine With or Without Aura
-
Avanir PharmaceuticalsCompleted