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Completed

NCT Number: NCT00330850

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

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Ear Diseases Epilepsy Eye Diseases Headache Disorders Headache Disorders, Primary Hearing Disorders Hyperacusis Migraine Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Phonophobia Photophobia Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Associated Neurologists of Southern CT, Fairfield, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRO-513

Drug

Sponsors and collaborators

Lead sponsor

ProEthic Pharmaceuticals

Industry

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
May 29, 2006
Registry last updated
Apr 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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