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A Study on the Usability of the Needle-Free Intraject® System in Adult Patients During Acute Migraine Attack
This study has been completed.
First Received: September 13, 2007   Last Updated: February 7, 2008   History of Changes
Sponsored by: Zogenix, Inc.
Information provided by: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT00530517
  Purpose

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 Intervention Phase
Migraine Headache
Device: Intraject Sumatriptan
Phase II

Study Type: Interventional
Study Design: Open Label, Active Control, Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Device: Intraject Sumatriptan
needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530517

Locations
United States, Illinois
Chicago, Illinois, United States, 60614
United States, Missouri
Springfield, Missouri, United States, 65807
St. Louis, Missouri, United States, 63141
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Zogenix, Inc.
Investigators
Principal Investigator: Jan Brandes, MD Nashville Neuroscience Group
  More Information

No publications provided

Responsible Party: Zogenix, Inc ( Stephen J. Farr, Ph.D/ President and COO )
Study ID Numbers: ZX001-0701
Study First Received: September 13, 2007
Last Updated: February 7, 2008
ClinicalTrials.gov Identifier: NCT00530517     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:
migraine
sumatripatan

Study placed in the following topic categories:
Serotonin Agonists
Sumatriptan
Neurotransmitter Agents
Migraine Disorders
Headache
Vasoconstrictor Agents
Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions
Headache Disorders
Sumatriptan
Serotonin Agents
Migraine Disorders
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on July 02, 2009