title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  German Clinical Trials Register DRKS00004716.
authors.affiliation: Department of Neurology, University Hospital Essen, Hufelandstraße 55, 45122 Essen, Germany.
authors.forename: Dagny
authors.initials: D
authors.lastname: Holle
authors.forename: Jan
authors.initials: J
authors.lastname: Burmeister
authors.forename: André
authors.initials: A
authors.lastname: Scherag
authors.forename: Claudia
authors.initials: C
authors.lastname: Ose
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Mark
authors.initials: M
authors.lastname: Obermann
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003027:Cluster Headache; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D010147:Pain Measurement; D000077402:Pantoprazole; D011241:Prednisone / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000893:Anti-Inflammatory Agents; D000077402:Pantoprazole; D011241:Prednisone
references.citation: Cephalalgia. 2002 Dec;22(10):815-7
references.pmid: 12485208
references.citation: J Lancet. 1952 Feb;72(2):92-8
references.pmid: 14908316
references.citation: Neurology. 2000 Mar 28;54(6):1382-5
references.pmid: 10746617
references.citation: Neurol Sci. 2003 Dec;24(5):318-21
references.pmid: 14716526
references.citation: Pain. 2005 Nov;118(1-2):92-6
references.pmid: 16202532
references.citation: Headache. 2003 Jul-Aug;43(7):784-9
references.pmid: 12890134
references.citation: Cephalalgia. 2005 Apr;25(4):290-5
references.pmid: 15773826
references.citation: Cephalalgia. 1983 Jun;3(2):109-14
references.pmid: 6409415
references.citation: Lancet Neurol. 2011 Oct;10(10):891-7
references.pmid: 21903477
references.citation: Dis Nerv Syst. 1975 Jul;36(7):375-6
references.pmid: 1097222
references.citation: Headache. 2004 Apr;44(4):361-4
references.pmid: 15109360
references.citation: JAMA. 1972 Dec 11;222(11):1403-4
references.pmid: 4678318
references.citation: Cephalalgia. 2004;24 Suppl 1:9-160
references.pmid: 14979299
references.citation: Headache. 1981 Jul;21(4):132-9
references.pmid: 7021473
references.citation: Eur J Neurol. 2006 Oct;13(10):1066-77
references.pmid: 16987158
references.citation: Med Care. 1996 Mar;34(3):220-33
references.pmid: 8628042
references.citation: Cephalalgia. 2007 Nov;27(11):1206-14
references.pmid: 17850348
references.citation: Headache. 1978 Sep;18(4):219-21
references.pmid: 721451
references.citation: Dtsch Arztebl Int. 2011 Aug;108(33):543-9
references.pmid: 21912573
references.citation: Qual Life Res. 2003 Dec;12(8):963-74
references.pmid: 14651415
references.citation: J Am Osteopath Assoc. 2002 Feb;102(2):92-4
references.pmid: 11866398
references.citation: Headache. 2002 Sep;42(8):787-92
references.pmid: 12390642
references.citation: Headache. 1995 Nov-Dec;35(10):607-13
references.pmid: 8550362
references.citation: Cephalalgia. 2002 Sep;22(7):520-2
references.pmid: 12230593
references.citation: Schmerz. 2005 Jun;19(3):225-41
references.pmid: 15887001
references.citation: Cephalalgia. 1989 Sep;9(3):195-8
references.pmid: 2507161
references.citation: Cephalalgia. 1996 Nov;16(7):494-6
references.pmid: 8933994
references.citation: Cephalalgia. 2002 Apr;22(3):186-9
references.pmid: 12047455
references.citation: Cephalalgia. 2002 Apr;22(3):205-8
references.pmid: 12047460
references.citation: Eur J Neurol. 2007 Jun;14(6):694-6
references.pmid: 17539953
references.citation: Neurology. 1958 Sep;8(9):653-63
references.pmid: 13578060
references.citation: Acta Neurol Scand. 1969;45(5):601-10
references.pmid: 4391566