Members of the Study Group and number of patients recruited: P. Krupp (16), T. Schmitt (16), G. Steitz (16), J. Schimek (13), M. Heim (12), T. Krohn (12), B. Fritsche (10), T. Nolte (9), B. Steinberg (9), R. Malek (8), F. Rövenich (8), B. Stolkzi (8), H.-D. Gross (7), H. Olbrich (7), B. Schwittmann (7), H. D. Beiküfner (6), B.-H. Gravenhorst (6), F. Huss (5), J.-P. Jansen (5), L. Ost-Müller (5), G. Stumpf (5), R. Hungerland (4), E. Imhof (4), L. Krause (4), H. H. Langohr (4), V. Boest (3), L. Braunsdorf (3), K. Gastmeier (3), H. Kayser (3), M. Mökesch (3), V. Richer (3), P. Bürgermeister (2), U. Eckhardt (2), J. Fuchs (2), A. Grünerbel (2), E. Lopez (2), H.-J. Schmidt (2), B. Halbroth (1), A. Straube (1), R. Thümler (1).
Cyclandelate in the prophylaxis of migraine:a placebo-controlled study
Article first published online: 20 DEC 2001
Volume 21, Issue 1, pages 66–70, January 2001
How to Cite
Diener, H., Krupp, P., Schmitt, T., Steitz, G., Milde, K., Freytag, S. and the Study Group (2001), Cyclandelate in the prophylaxis of migraine:a placebo-controlled study. Cephalalgia, 21: 66–70. doi: 10.1046/j.1468-2982.2001.00153.x
- Issue published online: 20 DEC 2001
- Article first published online: 20 DEC 2001
- Received 18 May 2000,accepted 11 December 2000
- Migraine prophylaxis;
- efficacy parameters
The prophylactic action of cyclandelate was investigated in a multicentre, randomized, placebo-controlled, parallel group study. A 4-week baseline period was followed by a 4-week placebo phase and a 16-week treatment period with either 1600 mg cyclandelate or placebo. Patients (n = 251) with two to six migraine attacks/month were randomized. Neither the primary study endpoint (reduction of migraine days from baseline to the last 28 days) nor most of the secondary endpoints (reduction in the number of migraine attacks, severity or duration of attacks, frequency of autonomic disturbances, medication for treatment of attacks) showed a difference between cyclandelate and placebo. Cyclandelate, however, was superior to placebo in a global impression of efficacy rated by the patients and the treating physicians. Both treatments were well tolerated. In conclusion, cyclandelate was not superior to placebo in the prophylaxis of migraine with regard to parameters usually used in migraine prophylaxis trials.