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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 : February 18, 2008
Sponsor:
Information provided by:
Zogenix, Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2007
First Posted Date  ICMJE September 17, 2007
Last Update Posted Date February 18, 2008
Study Start Date  ICMJE September 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack [ Time Frame: 30 Days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2007)
Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
Change History Complete list of historical versions of study NCT00530517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Usability of the Needle-Free Intraject® System in Adult Patients During Acute Migraine Attack
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Migraine Headache
Intervention  ICMJE Device: Intraject Sumatriptan
needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan
Study Arms  ICMJE Experimental: 1
Intervention: Device: Intraject Sumatriptan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2008)
54
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2007)
50
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530517
Other Study ID Numbers  ICMJE ZX001-0701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen J. Farr, Ph.D/ President and COO, Zogenix, Inc
Study Sponsor  ICMJE Zogenix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Brandes, MD Nashville Neuroscience Group
PRS Account Zogenix, Inc.
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP