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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00330850
First Posted: May 29, 2006
Last Update Posted: April 2, 2007
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.
Information provided by:
ProEthic Pharmaceuticals
May 26, 2006
May 29, 2006
April 2, 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
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
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