Abstract
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
Highlights
Episodic cluster headache (ECH) is a primary headache disorder that severely impairs patient’s quality of life
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
Episodic cluster headache (ECH) is a primary headache disorder characterized by intense unilateral attacks of facial and head pain lasting between 15 and 180 minutes accompanied by trigemino-autonomic symptoms
Summary
Design PredCH is a prospective, randomized, double-blind, placebo-controlled trial with two parallel interventional arms: all eligible patients with ECH will receive verapamil and will be 1:1 randomized to the treatment intervention with prednisone or placebo. General structure of the study The duration of the study for each patient is 28 days (including 17 days of treatment/placebo intervention) It consists of 4 visits (see Figure 1) including a screening visit, a randomization visit, and two follow-up visits during which therapy response, safety, and compliance will be assessed. During screening and follow up visits patients will participate in a safety assessment which will examine for pathological findings in medical and neurological examination and laboratory tests, abnormal vital parameters, adverse events and suspected adverse effects from study medication. This committee will analyze all severe adverse events, infections, drop-outs due to adverse medical effects and mortalities
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