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

This study has been completed.
Sponsor:
Information provided by:
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT00530517
First received: September 13, 2007
Last updated: February 7, 2008
Last verified: February 2008
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Zogenix, Inc.:
migraine
sumatripatan

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014