title: Efficacy and tolerance of cyclandelate versus pizotifen in the prophylaxis of migraine.
abstract: In a double-blind, parallel randomized study, the prophylactic efficacy and tolerance of cyclandelate was evaluated versus pizotifen over a period of 16 weeks in 84 patients with migraine. The trial was initiated with a single-blind four week placebo run-in phase (baseline) in order to eliminate placebo-responders and non-compliant patients (n = 23). Sixty-one patients qualified for the subsequent active treatment period of 12 weeks. Cyclandelate or pizotifen were administered at a dosage of 1600mg/day (800mg/placebo/800mg) or 0.5mg t.i.d., respectively. Cyclandelate was clinically effective in the prophylactic treatment of migraine as shown by an average reduction of greater than 60% in three migraine parameters; frequency of attacks (FA 77.6%), total pain index (TPI 64.0%) and number of awakenings with headache (AwH 72.7%). This clinical efficacy was significantly superior (p less than 0.01) to that seen with pizotifen in all migraine parameters throughout the study. An average reduction of about 50% in FA, TPI and AwH was already observed in the cyclandelate group after 4-6 weeks suggesting an early onset of action. Side-effects in the cyclandelate group were fewer and less pronounced than in the pizotifen group. All patients included in the active treatment period completed the study. Thus, we conclude that cyclandelate is an effective and well tolerated drug for the prophylactic treatment of migraine.
authors.affiliation: Institute of Neurological Science, Faculty of Medicine, University of Naples, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Mastrosimone
authors.forename: C
authors.initials: C
authors.lastname: Iaccarino
authors.forename: G
authors.initials: G
authors.lastname: de Caterina
mesh_terms: D000328:Adult; D000075202:Contraindications; D003495:Cyclandelate / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D010147:Pain Measurement / Q000187:drug effects; D010918:Pizotyline / Q000627:therapeutic use*
chemical_list: D010918:Pizotyline; D003495:Cyclandelate