PROMPT Clinical Trial for Migraine Prevention

Various national and local guidelines demand revision of migraine prevention therapy after 4 to 6 months of treatment. However, there is no evidence from clinical studies to support the validity of such guidance. The PROMPT (PROlonged Migraine Prevention with Topiramate) study was set up to address this issue and evaluate the efficacy of ‘Topamax’ (topiramate) in migraine prophylaxis (prevention) beyond 6 months.

Official Title

Conditions

Migraine

Study Type

Interventional

Study Design

Multicentre, double-blind, randomized and placebo-controlled. Following a 4-8 week baseline stage without any treatment, in which it was confirmed that patients had established frequent migraine (>4 migraine days every 4 weeks), study subjects entered a 26-week open-label phase where all received treatment with topiramate. Topiramate treatment was initiated at a daily dose of 25 mg and increased in weekly 25 mg increments to a target dose of 100 mg/day. Final doses could be adjusted between 50 and 200 mg per day, but were kept steady for the last month of this 6-month study stage. The modal dose was ~ 100 mg throughout the study. After the open-label stage, patients then entered the double-blind phase of the study where they were randomized to continue at their optimised dose of topiramate or switched to placebo, for a further 26 weeks.

Further Details

Primary Outcome Measures:

• Change in the number of migraine days (topiramate versus placebo) during the last 4 weeks of the double-blind phase relative to the last 4 weeks of the open-label phase.

Secondary Outcome Measures:

• The change in severity and duration of migraine headaches
• The change in acute medication use
• Quality of life
• Patient satisfaction with treatment

Results

• During the first 6 months of treatment with topiramate in the open label stage, the number of migraine days decreased by one third. The mean number of migraine days was reduced from 8.9 days per 4 weeks at baseline to 5.8 days after topiramate treatment, a significant reduction in migraine days of -3.1 per 4 weeks [p < 0.0001]
• During the double-blind study phase, there was a significant increase in migraine days in the placebo group (+1.2 days) compared with a sustained reduction in topiramate-treated patients, where the mean number of monthly migraine days remained virtually unchanged (+0.1 day) [p = 0.0011]

Study Start

Eligibility & Criteria

Confirmed that patients had established frequent migraine (>4 migraine days every 4 weeks)

Total Enrolment

559 patients completed the open-label phase. 512 progressed to the double-blind stage of the study.

Contact Details

For more detailed experimental results, also see this study