Clinical Trial: Frovatriptan as a Transitional Therapy in Medication Overuse Headache

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Frovatriptan as a Transitional Therapy in Medication Overuse Headache

Brief Summary: This study will analyze the effectiveness of a medication called Frovatriptan, in the context of medication overuse headache (MOH). MOH is a headache that develops when pain-killers are taken frequently. The treatment is to stop the overuse of these pain-killers, but that can sometimes worsen the headache first before it gets better. We are testing Frovatriptan against placebo to see if it can help patients with this transition and avoid the worsening of the headache that can occur. We will also see if Frovatriptan can help in other ways, such as maintain patients free of medication overuse.

Detailed Summary: A single-centre, randomized, placebo-controlled trial is proposed to assess Frovatriptan as a transitional therapy in patients diagnosed with medication overuse headache. Currently, there are no proven transitional therapies to help patients get through the detoxification process. Frovatriptan has not been tested as a transitional therapy in the past. This study will compare Frovatriptan, taken over a 10 day transitional period, to placebo. The primary outcome of the study will be the mean headache intensity in the 10 day transitional period in the Frovatriptan group as compared to the placebo group. A number of secondary and exploratory outcomes will also be determined and further data collection will occur at 1, 2, and 3 month periods. The duration of the study for the participants will be 3 months, and they will be asked to keep detailed headache diaries during this time. Ten days of baseline headache diaries will also be performed before patients can enter the study.
Sponsor: University of Calgary

Current Primary Outcome: The mean headache intensity in the 10 day transitional period in the Frovatriptan group as compared to the placebo group. [ Time Frame: After 10 days of therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The difference in mean headache intensity between the 10 day transitional period and the baseline period. [ Time Frame: After 10 days of therapy ]
  • The number of day segments with headache of grade 6 or higher during the 10 day transitional period and during days 11-20 of the study. [ Time Frame: After 10 days and after 20 days ]
  • Number of headache-free days (grade zero) for first two months of study. [ Time Frame: After 2 months ]
  • Proportion of patients free of medication overuse for first two months of study (i.e. less than 15 days of simple analgesic use or less than 10 days of other analgesic use per month). [ Time Frame: After 2 months ]


Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: January 5, 2010
Date Started: January 2010
Date Completion: September 2017
Last Updated: August 16, 2016
Last Verified: August 2016