German open label trial of riluzole 50 mg b.i.d. in treatment of amyotrophic lateral sclerosis (ALS).

Riluzole is currently the only drug that holds any hope of prolonging life in amyotrophic lateral sclerosis (ALS) by slowing the rate of disease progression.

RESULTS

Between 1995 and 1997 a total of 7916 ALS patients in 39 countries, were given 100 mg riluzole per day for a mean of 7.2 months. The present report focuses on the German results in comparison to the total population. Nine hundred and nineteen patients were treated in 25 German centres; 162 (17.6%) died from the disease during the course of the study. Serious adverse events attributed to the study medication occurred in 16 patients (1.7%). Most frequently these were reversible changes in liver enzymes (0.9%) occurring during the first 3 months, none resulted in death. In all, 413 patients (44.9%) reported an adverse event. The most frequent were reduced lung function (7.3%), nausea (7.1%), asthenia (5.8%), pneumonia (2.5%) and abdominal pain (2.5%).

CONCLUSIONS

The results of the study allow the conclusion that riluzole is well tolerated. The majority of adverse events were symptoms of the underlying disease and were not attributed to riluzole. Overall the safety profile found in the German centres was very similar to the profile seen in the total patient population and was more favourable than in the two published double-blind studies [New Engl J Med 330 (1994) 585; Lancet 347 (1996) 1425].