R-Verapamil in the Prophylaxis of Episodic Cluster Headache V.1

• Research type

  Research Study

• Full title

  A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prophylaxis of Episodic Cluster Headache

• IRAS ID

  113358

• Contact name

  Manjit Singh Matharu

• Sponsor organisation

  CENTER LABORATORIES, INC

• Eudract number

  2012-003729-62

• ISRCTN Number

  xx

• Research summary

  This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prevention of episodic cluster headache. The study will consist of a 1-week run-in period and a 2-week treatment period (R-verapamil or placebo). There will be 15 participants per group. Participants who consent to the study will undergo screening. Participants who meet the selection criteria will enter into a 7-day run-in period, where they will record the frequency of their cluster headaches and the use of rescue medication. No study drug will be administered during the run in period. At Visit 2, those participants that experienced at least 7 attacks/week will be randomized to receive one of the following treatments for 2 weeks: Group I: R- verapamil as one 75 mg tablet in the morning, two 75 mg tablets in the afternoon and two 75 mg tablets at bedtime daily during Days 8-21. Total dose 375mg/day Group II: Placebo as 1 placebo tablet in the morning, 2 placebo tablets in the afternoon and 2 placebo tablets at bedtime daily during Days 8-21. The treatment with R-verapamil will be blinded (neither participant nor the doctor will know, to which group was the participant'ssigned to). Participants will return on Day 15 and on Day 22, the final study visit. After the end of study procedures have been completed, participants will be discharged from the study. All participants in the study will have access to their normal rescue medication during the trial.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/1703

• Date of REC Opinion

  16 Jan 2013

• REC opinion

  Further Information Favourable Opinion