Topiramate Clinical Data

All commercially insured patients new to Trokendi XR pay nothing for a minimum of 12 prescriptions*—guaranteed.

*Click here for Terms and Conditions.

Topiramate is a highly effective molecule for migraine prevention, depending on how it is dosed1,3

Chart showing significant reductions in migraine frequency with Toprimate

Study design1,2:

Two multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials were conducted to establish the effectiveness of immediate-release topiramate in the prophylactic treatment of migraine headache. Study 1 was conducted in the United States and Study 2 was conducted in the United States and Canada. The design of both trials was identical, enrolling patients 12 years to 65 years of age with a history of migraine, with or without aura, for at least 6 months, according to the IHS diagnostic criteria.

Patients were excluded from the trials if they experienced headaches other than migraine, episodic tension, or sinus headaches. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. Patients who experienced 3 to 12 migraine headaches over a 28-day prospective baseline phase were randomized to either topiramate 50 mg/day, 100 mg/day, 200 mg/day, or placebo, and treated for a total of 26 weeks (8-week titration period and 18-week maintenance period). Treatment was initiated at 25 mg/day for one week, and then the daily dosage was increased by 25 mg increments each week until reaching the assigned target dose or maximum tolerated dose (administered twice daily). Effectiveness of treatment was assessed by the reduction in migraine headache frequency, as measured by the change in 4-week migraine rate (according to migraine classified by IHS criteria) from the baseline phase to double-blind treatment period in each topiramate treatment group, compared to placebo, in the intent-to-treat population.

100 mg is the recommended total daily dose of topiramate.1,2,5

Topiramate dosed at 100 mg/day has a statistically significant responder rate1,5

Graphic showing significant decrease in monthly rescue medication days for patients treated with Toprimate

Statistically significantly different than placebo. Adapted from Silberstein et al 2004.1

Secondary endpoint: change in number of days requiring rescue medication from the end of the baseline phase through the double-blind phase. The mean ± SD monthly acute rescue medication days were significantly reduced for the groups treated with topiramate 200 mg/day (from 6.1 ± 2.6 to 4.0 ± 2.8; P =0.002), and topiramate 100 mg/day (from 5.9 ± 2.5 to 4.0 ± 3.4; P =0.005), compared with placebo (from 6.1 ± 3.0 to 5.2 ± 3.3), but not for those treated with topiramate 50 mg/day (from 5.8 ± 2.5 to 4.5 ± 3.1; P =0.12). Similar results were seen in the second randomized controlled trial.

Trokendi XR® (topiramate) was designed and is approved for QD dosing3,6

Example of same-day conversion for patients taking twice-daily Topamax® (topiramate)3 No washout—no titration
TOPAMAX 50 BID equals Trokendi XR® (topiramate) 100 mg QD

Tablets and capsule shown are not actual size.

Recommended dose of Trokendi XR (topiramate) for migraine prophylaxis is 100 mg/day.6

  1. Identify immediate-release topiramate patients and convert to Trokendi XR (topiramate)
  2. Titrate to total daily dose of 100 mg, where appropriate6

Dosing for Trokendi XR (topiramate)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS & PRECAUTIONS

DOSING GUIDELINES & CONSIDERATIONS

ADVERSE REACTIONS

 

INDICATION

Please refer to the full Prescribing Information and Medication Guide for additional important information on Trokendi XR.

Trokendi XR (topiramate) extended-release capsules

 

REFERENCES:

  1.  Silberstein SD, Neto W, Schmitt J, Jacobs D; for MIGR-001 Study Group. Topiramate in migraine prevention. Arch Neurol. 2004;61:490-495.
  2. Brandes JL, Saper JR, Diamond M, et al. Topiramate for migraine prevention: a randomized controlled trial. J Amer Med Assoc. 2004;291:965-973.
  3. Data on file. Supernus Pharmaceuticals, Inc.
  4. Topamax [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; June 2018.
  5. Bussone G, Diener H-C, Pfeil J, Schwalen S. Topiramate 100 mg/day in migraine prevention: a pooled analysis of double-blind randomized controlled trials. Int J Clin Pract. 2005;59:961-968.
  6. Trokendi XR [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; January 2018.