• Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-Christoph Diener, Mark Obermann, and PredCH Study Group.
• Department of Neurology, University Hospital Essen, Hufelandstraße 55, 45122 Essen, Germany.
• Bmc Neurol. 2013 Jan 1;13:99.

BackgroundEpisodic cluster headache (ECH) is a primary headache disorder that severely impairs patient's quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of cluster attacks in the beginning of a cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a cluster episode.Methods And DesignPredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with episodic cluster headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German headache clinics that specialize in the treatment of ECH.DiscussionPredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of cluster attacks in the beginning of a cluster episode as compared to monotherapy with verapamil.Trial RegistrationGerman Clinical Trials Register DRKS00004716.

11 keywords...

hide…