An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack

This study has been completed.
Sponsor:
Information provided by:
ProEthic Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00330850
First received: May 26, 2006
Last updated: March 30, 2007
Last verified: March 2007

May 26, 2006
March 30, 2007
May 2006
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Complete list of historical versions of study NCT00330850 on ClinicalTrials.gov Archive Site
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An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
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The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.

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Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
  • Migraine
  • Photophobia
  • Phonophobia
Drug: PRO-513
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
December 2006
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Inclusion Criteria:

  • Male and Female subjects
  • 18-65 years of age
  • Primary diagnosis of migraine attack with aura or migraine attack without aura
  • Migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year
  • Female subjects must use an effective form of birth control
  • Listing of additional inclusion criteria are available through the Sponsor

Exclusion Criteria:

  • Excluding subjects with a history of other serious events causing secondary headaches
  • Excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication
  • Excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug
  • Listing of additional exclusion criteria are available through the Sponsor
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00330850
PRO-513301
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ProEthic Pharmaceuticals
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Principal Investigator: Richard Lipton, MD Montefiore Headache Center
ProEthic Pharmaceuticals
March 2007

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