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Prophylactic Treatment of Episodic Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00184587
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 23, 2013
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date April 23, 2013
Study Start Date  ICMJE March 2005
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
frequency of attacks per week [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
frequency of attacks per week
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
  • level of disability [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
    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 ]
  • hours with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  • days with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  • occurrence of autonomic symptoms [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  • number of treatments with sumatriptan or oxygen [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  • patient satisfaction with treatment [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
    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 ]
    product of level of disability and duration of attacks
  • candesartan-responders [ Time Frame: 3 weeks ]
    patients with a 50% or more reduction in attack frequency in week 3 than in week 1
  • placebo-responders [ Time Frame: 3 weeks ]
    patients with a 50% or more reduction in attack frequency in week 3 than in week 1
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • level of disability
  • duration of attacks
  • hours with cluster headache
  • days with cluster headache
  • hours with headache
  • days with headache
  • occurrence of autonomic symptoms
  • number of attacks treated with sumatriptan or oxygen
  • doses of sumatriptan
  • acceptability of treatment
  • comparison between the last two weeks on medication and yhe week with headache diary only
  • days with sick leave
  • headache severity index
  • doses of analgesics
  • candesartan-responders
  • placebo-responders
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Treatment of Episodic Cluster Headache
Official Title  ICMJE Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study
Brief Summary The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cluster Headache
Intervention  ICMJE
  • Drug: candesartan cilexetil
    Other Name: angiotensin II receptor blocker
  • Drug: placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: candesartan cilexetil
  • 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
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2013)
40
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
64
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00184587
Other Study ID Numbers  ICMJE D2452L0004
2004-002737-39 ( EudraCT Number )
045-04 ( Other Identifier: Norwegian National Headache Centre )
10815 ( Other Identifier: NSD )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Lars J Stovner, PhD Norwegian National Headache Center St.Olavs Hospital
PRS Account Norwegian University of Science and Technology
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP