A placebo-controlled crossover trial of nimodipine in pediatric migraine.
An 8-month, double-blind, placebo-controlled crossover trial was carried out on the use of nimodipine in migraine prophylaxis in 37 patients aged 7 to 18 years old. After a 4-week medication-free run-in period, 19 subjects (Group 1) received a placebo while 18 (Group 2) received nimodipine (10-20 mg t.i.d., according to body weight), for 12 weeks. After a 4-week wash-out period, the groups switched therapy for a further 12 weeks. 30 patients completed the trial and the number of dropouts was comparable in the 2 groups. The only side-effect during nimodipine treatment was mild abdominal discomfort (3 cases). The treatments were evaluated on the basis of frequency and duration of attacks. There was a significant reduction in both parameters during the first period of treatment. During the second period of treatment, nimodipine proved to have a significantly greater effect than the placebo with regard to frequency, whereas the response was similar with the placebo as regards duration of attacks. The latter parameter shows a significant decrease during the treatment periods, regardless of type of therapy.
Department of Pediatrics, University of Padua, Italy.
P A
PA
Battistella
R
R
Ruffilli
R
R
Moro
M
M
Fabiani
S
S
Bertoli
A
A
Antolini
F
F
Zacchello
D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy* / Q000503:physiopathology; D009553:Nimodipine / Q000627:therapeutic use*; D010919:Placebos; D013997:Time Factors
D010919:Placebos; D009553:Nimodipine