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Open Access Study protocol

Study protocol of Prednisone in episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episodic cluster headache with verapamil

Dagny Holle1, Jan Burmeister1*, André Scherag2, Claudia Ose2, Hans-Christoph Diener1, Mark Obermann1 and on behalf of the PredCH Study Group

Author Affiliations

1 Department of Neurology, University Hospital Essen, Hufelandstraße 55, 45122, Essen, Germany

2 Center for Clinical Trials, Essen (ZKSE) and Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Hospital Essen, Hufelandstraße 55, 45122, Essen, Germany

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BMC Neurology 2013, 13:99  doi:10.1186/1471-2377-13-99

Published: 28 July 2013

Abstract

Background

Episodic 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 design

PredCH 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.

Discussion

PredCH 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 registration

German Clinical Trials Register DRKS00004716

Keywords:
Episodic cluster headache; Prednisone; Verapamil; Prophylactic treatment; Clinical trial; Prospective study; Study protocol