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A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00530517
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : November 10, 2022
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Headache Device: Intraject Sumatriptan Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Sumatriptan

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Device: Intraject Sumatriptan
needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack [ Time Frame: 30 Days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530517


Locations
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United States, Illinois
Chicago, Illinois, United States, 60614
United States, Missouri
Saint Louis, Missouri, United States, 63141
Springfield, Missouri, United States, 65807
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Zogenix, Inc.
Investigators
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Principal Investigator: Jan Brandes, MD Nashville Neuroscience Group
More Information
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Responsible Party: Stephen J. Farr, Ph.D/ President and COO, Zogenix, Inc
ClinicalTrials.gov Identifier: NCT00530517    
Other Study ID Numbers: ZX001-0701
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: February 2008
Keywords provided by UCB Pharma:
migraine
sumatripatan
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
 Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs