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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 10 days of treatment with placebo in a bid fashion that will look like the study medication. |
|
| Frovatriptan | Experimental | Frovatriptan 2.5 mg po bid for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frovatriptan | Drug | 2.5 mg po bid for 10 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The mean headache intensity in the 10 day transitional period in the Frovatriptan group as compared to the placebo group. | After 10 days of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in mean headache intensity between the 10 day transitional period and the baseline period. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner J Becker, MD, FRCPC | University of Calgary | Study Director |
| Farnaz Amoozegar, MD, FRCPC | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Health Campus | Calgary | Alberta | T3M 1M4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18483706 | Background | Grazzi L, Andrasik F, Usai S, Bussone G. Headache with medication overuse: treatment strategies and proposals of relapse prevention. Neurol Sci. 2008 Apr;29(2):93-8. doi: 10.1007/s10072-008-0867-8. Epub 2008 May 16. | |
| 18823363 | Background | Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24. |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C108128 | frovatriptan |
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| Drug |
1 tab po bid for 10 days |
|
| After 10 days and after 20 days |
| Number of headache-free days (grade zero) for first two months of study. | 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). | After 2 months |
| 18728819 | Background | Kelman L. Review of frovatriptan in the treatment of migraine. Neuropsychiatr Dis Treat. 2008 Feb;4(1):49-54. doi: 10.2147/ndt.s1871. |
| 18001261 | Background | Markus F, Mikko K. Frovatriptan review. Expert Opin Pharmacother. 2007 Dec;8(17):3029-33. doi: 10.1517/14656566.8.17.3029. |
| D051270 | Headache Disorders, Primary |