A study of the effects that telmisartan has on the body's uptake of verapamil, and the preventative effects of verapamil on clusterheadache.

Active, not recruiting

• Conditions: Horton's Headache; MedDRA version: 14.1Level: LLTClassification code 10020397Term: Horton's headacheSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2011-003513-41-DK
• Lead Sponsor: Danish Headache Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-22
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Phase 1: Healthy volunteers
Phase 2: Horton's Headache patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Poor general health, intolerance to drugs being investigated, pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase 2: To investigate the prophylactic effect of adding telmirsatan to verapamil in patients with cluster hehadache; a double blinded and placebo controlled design. ;Secondary Objective: Phase 1: To investigate an eventual change in the absorption of verapamil after adding telmisartan - a pharmacokinetic study. ;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: Phase 1: 2 weeks<br>Phase 2: 3 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A