my personal edition > migraine > news


  E-Mail this DGNews to a colleague

DGNews

New Study Shows Topamax (Ropiramate) Can Reduce Frequency of Migraine Headaches: Presented at MTIRS

Preventive Treatment Targets Chronic Sufferers of One of World's Most Disabling Conditions

LONDON, ENGLAND -- September 23, 2002 -- A new, Phase III study presented today at the 14^th annual meeting of The Migraine Trust International Research Symposium shows Topamax® (topiramate) can significantly reduce the frequency of monthly migraine-headache episodes in chronic sufferers.

Migraine headaches are listed by the World Health Organization as one of the most disabling chronic health conditions, and are estimated to affect 18 percent of women and 6 percent of men in the United States. More than half of migraine attacks (58 percent) are severe enough to require bed rest, leading to an estimated 81 million missed workdays in the United States every year.

"When migraine episodes start occurring once or more a week, as it does for about one out of every five sufferers, the disability is significant," said Stephen Silberstein, MD, principal investigator for the study and director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, PA. "At that point, it's time -- for the sake of the patient -- to start taking serious steps to prevent the attacks from coming on, rather than rely only on acute treatment when an episode has already begun. But there is only so much a patient can do through lifestyle changes, and few medications have shown efficacy in prevention."

Dr. Silberstein, presenting this week at the Migraine Trust, is one of the investigators in a large research program looking at the prophylaxis potential of Topamax, an anticonvulsant medication currently approved around the world for the management of various types of epileptic seizures. In the United States, Topamax is marketed by Ortho-McNeil Pharmaceutical, Inc., and is approved as adjunctive (add-on) therapy for adults and children aged 2-16 with partial-onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age or older with seizures associated with Lennox-Gastaut syndrome. The Phase III study in migraine prophylaxis, along with other research, will serve as the basis for an application to be filed with the U.S. Food and Drug Administration, seeking approval to market the medication for the new indication.

In the study presented at The Migraine Trust meeting in London, 469 patients who had been suffering from migraine headaches for at least one year at an average frequency of nearly five migraines per month, participated in a 26-week, randomized, double-blind comparison of three doses of Topamax (50 mg, 100 mg or 200 mg per day) to an inactive placebo.

The primary measure of efficacy in the study was the reduction in the average monthly number of migraine periods (defined as time spent in pain, up to 24 hours per period). At the conclusion of the study, patients receiving the two higher doses of Topamax had experienced a statistically significantly greater reduction in number of migraine episodes than those who took placebo. (At the 100 mg dose considered to be optimal in terms of tolerability and efficacy, the number of migraine periods dropped from an average of 5.4 per month at the start of the study to 3.3. The 200 mg Topamax group decreased from an average of 5.6 periods to 3.3. In contrast, the patients who took placebo went from 5.6 to 4.6. These results represent a reduction in migraine periods of 39 percent and 41 percent for the 100 and 200 mg doses of Topamax, respectively, vs. 18 percent for placebo.)

A secondary measure of efficacy was the percentage of individuals who experienced a 50 percent or greater reduction in the average monthly number of migraine periods. The differences between all doses of Topamax and placebo were statistically significant. Fifty-four percent of the patients who received 100 mg of Topamax daily were considered "responders" by this definition, compared to 52 percent who received 200 mg of the medication, 36 percent who took 50 mg and 23 percent of those who took placebo.

Patients' body weight also was assessed during the study, with their weight at the start of the research compared to their weight at the end of the study. The body weight of patients who received either 100 or 200 mg of Topamax dropped 3.8 percent over the course of the study. With 50 mg, the difference from placebo was still seen, but was lower (2.4 percent). In contrast, patients who took placebo gained 0.3 percent in body weight.

Adverse side effects were generally dose-dependent. Among the patients receiving 100 mg of Topamax daily, 20 percent dropped out of the study due to side effects. This was true for 33 percent who took 200 mg of Topamax, 17 percent who received 50 mg of the medication and 10 percent of those assigned to take placebo. At the 100 mg dose of Topamax, the most common side effects that occurred at least twice as often in the topiramate group compared to those who took placebo included paresthesia (sensation of pins and needles in the extremities), loss of appetite, anxiety, language problems (primarily articulation or "word-finding"), memory difficulties, mood changes and nervousness. Other common side effects occurring more often in patients taking topiramate included taste changes and weight loss. When they occur, these side effects are temporary or resolve once the medication is discontinued.

Based in Raritan, NJ, Topamax marketer Ortho-McNeil is a wholly owned subsidiary of Johnson & Johnson and markets pharmaceutical products in several therapeutic categories, including central nervous system disorders, infectious diseases, wound healing and women's health.

In clinical trials of Topamax for the currently approved epilepsy indication, the most common side effects observed in children included excessive drowsiness, loss of appetite, fatigue, nervousness, difficulty with concentration/attention, weight loss, aggressive reaction and memory difficulties. In adults, the most common side effects were sleepiness, dizziness, poor coordination, speech difficulties, slowed thinking, blurred or double vision, memory difficulties and changes in sensation. However, these effects were generally temporary.

For more information, read the full U.S. prescribing information, available upon request by calling 1-800-682-6532 or by visiting http://www.topamax.com or http://www.ortho-mcneil.com .


SOURCE: Ortho-McNeil Pharmaceutical

E-Mail this DGNews to a colleague

To print, use this version