This trial is active, not recruiting.

Condition episodic cluster headache
Treatments r-verapamil 75 mg tablet, placebo
Phase phase 2
Sponsor Center Laboratories, Inc.
Start date November 2013
End date December 2016
Trial size 30 participants
Trial identifier NCT02209155, R-Verapamil-001


This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Active Comparator)
375 mg/day; one in the morning, two in the afternoon and two at bedtime daily
r-verapamil 75 mg tablet
(Placebo Comparator)
one in the morning, two in the afternoon and two at bedtime daily

Primary Outcomes

Change in the average daily frequency of attacks
time frame: 2 weeks

Secondary Outcomes

Change in the average daily frequency of attacks
time frame: 1 week
Change in intensity of attacks
time frame: 2 weeks
Change in duration of attacks
time frame: 2 weeks
Change in consumption of abortive agents
time frame: 2 weeks
Patient acceptability of treatment
time frame: 2 weeks
Change in headache severity index
time frame: 2 weeks
Change in Hit-6 disability score
time frame: 2 weeks
R-verapamil and Placebo responders
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Healthy man or woman between the ages of 18 and 65 - In good health as determined by medical history and medical examination - Has a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition) - Has a lifetime prevalence of at least 2 prior cluster bouts - Subjects must experience at least 7 attacks/week during the run-in baseline period - Subjects must have a typical cluster period lasting at least 1 month. Subjects must be present in active cluster period and the expected remaining duration of the cluster cycle must be at least 3 weeks from Baseline Day 1 visit - Able to differentiate other headache types from cluster headaches - Is using or agrees to use a medically acceptable form of contraception(female of child-bearing potential) - Negative urine pregnancy test prior to study entry(female of child-bearing potential) - Concomitant medication that, in the opinion of the investigator and the patient's general practitioner(GP), do not pose an unacceptable risk based upon the prescribing information for verapamil - Able to understand and comply with all study requirements - Written informed consent Exclusion Criteria: - Women who are pregnant or lactating - Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability - Use of any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication - The concomitant use of beta blockers - The consumption of grapefruit juice - Allergic to or has shown hypersensitivity to verapamil or agents similar to verapamil - Abuses opioids or has a history of significant drug or alcohol abuse within the past year as determined by investigator - Has participated in an investigational drug trial in the 30 days prior to the screening visit - Has liver or kidney disease - Has a cardiopathology contraindicating verapamil administration - Subjects with previous adynamic ileus. - Subjects with chronic cluster headache - Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion

Additional Information

Official 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
Description Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in period and a 2-week treatment period (R-verapamil or placebo). The total duration of the study for each treatment group is 3 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Center Laboratories, Inc..