Clinical Trial: Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.

Detailed Summary: Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity., Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.
Sponsor: CoLucid Pharmaceuticals

Current Primary Outcome: Headache response, defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache two hours after intake of study drug. [ Time Frame: Two hours after intake of study drug ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Headache free (absence of headache) [ Time Frame: Two hours after intake of study drug ]
  • Headache severity (4 point scale: none, mild, moderate, severe) [ Time Frame: From time immediately before intake of study drug until 2 hours after after intake of study drug ]
  • Headache recurrence [ Time Frame: Within 24 hours hours after after intake of study drug ]
  • Presence or absence of nausea, phonophobia, photophobia, vomiting [ Time Frame: From time immediately before intake of study drug until 2 hours after intake of study drug ]
  • Disability (4 point scale: not at all, mild interference, marked interference, completely - needs bed rest) [ Time Frame: From time immediately before intake of study drug until 2 hours after intake of study drug ]
  • Requirement for rescue medication (yes or no) [ Time Frame: Between 2 and 24 hours after intake of study drug ]
  • Patient global impression (7 point scale) [ Time Frame: Between 2 hours after intake of study drug ]
  • Time to headache relief and time to pain free [ Time Frame: Within 24 hours after intake of study drug ]
  • Adverse events (spontaneously reported) [ Time Frame: Throughout the whole study duration ]
  • 12-Lead electrocardiograms (ECGs) [ Time Frame: Baseline and within 14 days after treatment ]
  • Vital signs [ Time Frame: Baseline and within 14 days after treatment ]
  • Clinical laboratory parameters [ Time Frame: Baseline and within 14 days after treatment ]
  • Physical examination [ Time Frame: Baseline and within 14 days after treatment ]


Original Secondary Outcome: Same as current

Information By: CoLucid Pharmaceuticals

Dates:
Date Received: April 16, 2009
Date Started: July 2009
Date Completion:
Last Updated: April 22, 2010
Last Verified: April 2010