Prophylactic Treatment of Episodic Cluster Headache

Cluster Headache Clinical Trial

Official title:

Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184587
• Other study ID #: D2452L0004
• Secondary ID: 2004-002737-3904
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 22, 2013
• Start date: March 2005
• Est. completion date: December 2009

Study information

• Verified date: September 2010
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache

Description:

Cluster headache is an unilateral headache with periodic attacks, that usually lasts for 6 to 12 weeks. The pain is usually unbearable. The attacks are treated with injections of sumatriptan (migraine medication)and inhalation of oxygen.

The most common prophylactics today has limited effect and a risk of side effects.

Candesartan has in one study shown a clinically significant effect in migraine prophylaxis.

The angiotensin II receptor blocker, candesartan is well tolerated with side-effects not significantly different from placebo and with few drug interactions. We therefore wish to investigate the prophylactic effect in treatment of cluster in headache patients.

This will be a multicenter, double-blind, randomized, parallel study where the prophylactic effect of candesartan is compared to placebo in a period of 3 weeks. First week 16 mg and the following 2 weeks 32 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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. At the time of inclusion, the cluster headache period shall not have lasted more than 3 weeks

Exclusion Criteria:

• Pregnancy, nursing, decreased hepatic og renal function, psychiatric illness, cardiac problems, hypersensitivity to candesartan, previous serious allergic reaction to medication, chronic cluster headache, drug/alcohol abuse, use of antipsychotic,antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion, systolic blood pressure below 110 mmHg, use of other hypertensive medication, use og other specific attack medication than sumatriptan injection or oxygen 7-10l/min and inability to change medication, use of other triptans than sumatriptan during the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Drug:
• candesartan cilexetil

• placebo

Locations

Country	Name	City	State
Norway	Norwegian National Headache Centre St.Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	AstraZeneca

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Tronvik E, Stovner LJ, Helde G, Sand T, Bovim G. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomized controlled trial. JAMA. 2003 Jan 1;289(1):65-9. — View Citation

Tronvik E, Wienecke T, Monstad I, Dahløf C, Bøe MG, Tjensvoll AB, Salvesen R, Zwart JA, Jansson SO, Stovner LJ. Randomised trial on episodic cluster headache with an angiotensin II receptor blocker. Cephalalgia. 2013 Sep;33(12):1026-34. doi: 10.1177/03331 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of attacks per week		change from 'pseudobaseline' week 1 to week 3	No
Secondary	level of disability	5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable	change from 'pseudobaseline' week 1 to week 3	No
Secondary	duration of attacks		change from 'pseudobaseline' week 1 to week 3	No
Secondary	hours with cluster headache		change from 'pseudobaseline' week 1 to week 3	No
Secondary	days with cluster headache		change from 'pseudobaseline' week 1 to week 3	No
Secondary	occurrence of autonomic symptoms		change from 'pseudobaseline' week 1 to week 3	No
Secondary	number of treatments with sumatriptan or oxygen		change from 'pseudobaseline' week 1 to week 3	No
Secondary	patient satisfaction with treatment	scale from 1 to 10 with 1= very poor effect and 10= very good effect	change from 'pseudobaseline' week 1 to week 3	No
Secondary	headache severity index	product of level of disability and duration of attacks	change from baseline to 1 week and 3 week	No
Secondary	candesartan-responders	patients with a 50% or more reduction in attack frequency in week 3 than in week 1	3 weeks	No
Secondary	placebo-responders	patients with a 50% or more reduction in attack frequency in week 3 than in week 1	3 weeks	No