Prophylactic Treatment of Episodic Cluster Headache

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184587
First received: September 13, 2005
Last updated: April 22, 2013
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Cluster Headache
Drug: candesartan cilexetil
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • frequency of attacks per week [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • level of disability [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]
    5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable

  • duration of attacks [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]
  • hours with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]
  • days with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]
  • occurrence of autonomic symptoms [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]
  • number of treatments with sumatriptan or oxygen [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]
  • patient satisfaction with treatment [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ] [ Designated as safety issue: No ]
    scale from 1 to 10 with 1= very poor effect and 10= very good effect

  • headache severity index [ Time Frame: change from baseline to 1 week and 3 week ] [ Designated as safety issue: No ]
    product of level of disability and duration of attacks

  • candesartan-responders [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    patients with a 50% or more reduction in attack frequency in week 3 than in week 1

  • placebo-responders [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    patients with a 50% or more reduction in attack frequency in week 3 than in week 1


Enrollment: 40
Study Start Date: March 2005
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: candesartan
candesartan cilexetil 16 mg (one tablet/day) in week 1 and 32 mg (2 tablets/day) in week 3, provided for the study by AstraZeneca
Drug: candesartan cilexetil
Other Name: angiotensin II receptor blocker
Placebo Comparator: placebo
placebo one tablet/day in week 1 and 2 tablets/day in week 3, provided for the study by AstraZeneca. Same size, weight, taste and appearance as experimental drug
Drug: placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184587

Locations
Norway
Norwegian National Headache Centre St.Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
AstraZeneca
Investigators
Principal Investigator: Lars J Stovner, PhD Norwegian National Headache Center St.Olavs Hospital
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184587     History of Changes
Other Study ID Numbers: D2452L0004, 2004-002737-39, 045-04, 10815
Study First Received: September 13, 2005
Last Updated: April 22, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
prophylactic
episodic
cluster
candesartan
angiotensin II receptor blocker
randomized placebo controlled parallel study
headache diary

Additional relevant MeSH terms:
Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Angiotensin II
Candesartan cilexetil
Candesartan
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014