NCT00184587

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 23, 2013

Status Verified

September 1, 2010

Enrollment Period

4.3 years

First QC Date

September 13, 2005

Last Update Submit

April 22, 2013

Conditions

Cluster Headache

Keywords

prophylacticepisodicclustercandesartanangiotensin II receptor blockerrandomized placebo controlled parallel studyheadache diary

Outcome Measures

Primary Outcomes (1)

  • frequency of attacks per week

    change from 'pseudobaseline' week 1 to week 3

Secondary Outcomes (10)

  • level of disability

    change from 'pseudobaseline' week 1 to week 3

  • duration of attacks

    change from 'pseudobaseline' week 1 to week 3

  • hours with cluster headache

    change from 'pseudobaseline' week 1 to week 3

  • days with cluster headache

    change from 'pseudobaseline' week 1 to week 3

  • occurrence of autonomic symptoms

    change from 'pseudobaseline' week 1 to week 3

  • +5 more secondary outcomes

Study Arms (2)

candesartan

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

candesartan cilexetilDRUG
Also known as: angiotensin II receptor blocker
candesartan
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian National Headache Centre St.Olavs Hospital

Trondheim, Trondheim, 7006, Norway

Location

Related 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. doi: 10.1001/jama.289.1.65.

    PMID: 12503978BACKGROUND

  • Tronvik E, Wienecke T, Monstad I, Dahlof C, Boe 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: 10.1177/0333102413484989. Epub 2013 Apr 18.

    PMID: 23598371RESULT

MeSH Terms

Conditions

Cluster HeadacheRecurrence

Interventions

candesartan cilexetilAngiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Lars J Stovner, PhD

    Norwegian National Headache Center St.Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

April 23, 2013

Record last verified: 2010-09

Locations

NO(1)