Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine
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|ClinicalTrials.gov Identifier: NCT00210496|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Migraine Classic Migraine Common Migraine||Drug: topiramate; almotriptan malate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of AXERT (Almotriptan Malate) in the Acute Treatment of Migraine: A Pilot Study of the Potential Impact of Preventive Therapy With TOPAMAX (Topiramate)|
|Study Start Date :||June 2005|
|Actual Study Completion Date :||June 2007|
U.S. FDA Resources
- The primary effectiveness parameter will be the proportion of subjects in each treatment group who achieve a Sustained Pain Free (SPF) response during the first qualifying headache of the Assessment Period.
- For first headache of the Assessment Period, Pain relief at 2 hours; Pain free at 2 hours; Maximum intensity of headache pain; Headache duration; Rescue medication use; Maximum intensity of migraine associated symptoms (photophobia, phonophobia, nausea).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210496
|Study Director:||Janssen Ortho LLC Clinical Trial||Janssen-Ortho LLC|