Prophylactic treatment of episodic cluster headache with an angiotensin II receptor blocker (candesartan cilexetil); a randomized, placebo controlled parallel study. - Cluster-candesartan study

• Conditions: Episodic cluster headache

• Registration Number: EUCTR2004-002737-39-DK
• Lead Sponsor: ational Headache Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

-Signed, written informed consent
-Male or female aged 18-75.
-At the time of inclusion, the cluster headache period shall not have lasted more than
3 weeks.
-The episodic cluster headache must be diagnosed according to the IHS classification.
-Had at least one episode with cluster headache before inclusion.
-Previously had at least one cluster headache episode lasting one month or more.
-The patient can separate the cluster headache from other types of headache.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnancy, nursing or inability to use contraceptives
-Decreased hepatic or renal function.
-Systolic blood pressure below 110 mmHg
-Hypersensitivity towards candesartan cilexetil.
-Previous history of serious allergic reaction to a medication.
-Psychiatric illness preventing full participation.
-Use of lithium within 4 weeks prior to inclusion and within 2 weeks for other
cluster headache prophylactic medications.
-Cardiac problems
-Use of diuretics
-Use of other specific attack medication than sumatriptan or oxygen 7-10 l/min and
the inability to change to this medication. (Pain killers like acetylic acid,
paracetamol, ibuprofen etc. is allowed).
-Use of other triptans than sumatriptan or ergotamines during the study period.
-Chronic cluster headache.
-Those who abuse drugs, including headache treatments, and alcohol.
-The use of antipsychotics or antidepressants one month prior to inclusion.

Study & Design

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