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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02209155
Other study ID # R-Verapamil-001
Secondary ID
Status Terminated
Phase Phase 2
First received August 4, 2014
Last updated April 9, 2018
Start date November 2013
Est. completion date March 2018

Study information

Verified date April 2018
Source Center Laboratories, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
R-verapamil 75 mg tablet

Placebo


Locations

Country Name City State
United Kingdom UCLH/UCL NIHR Clinical Research Facility London

Sponsors (1)

Lead Sponsor Collaborator
Center Laboratories, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events assessments 2 weeks
Primary Change in the average daily frequency of attacks 2 weeks
Secondary Change in the average daily frequency of attacks 1 week
Secondary Change in intensity of attacks 2 weeks
Secondary Change in duration of attacks 2 weeks
Secondary Change in consumption of abortive agents 2 weeks
Secondary Patient acceptability of treatment 2 weeks
Secondary Change in headache severity index 2 weeks
Secondary Change in Hit-6 disability score 2 weeks
Secondary R-verapamil and Placebo responders 2 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01341548 - Civamide Nasal Solution for Cluster Headache Phase 3
Unknown status NCT00399243 - Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache Phase 4
Completed NCT02397473 - A Study Of Galcanezumab In Participants With Episodic Cluster Headache Phase 3
Completed NCT02797951 - A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache Phase 3
Completed NCT00033839 - A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache Phase 3
Terminated NCT02945046 - A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH) Phase 3
Completed NCT00069082 - Intranasal Civamide for Episodic Cluster Headache Phase 3