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Candesartan Versus Propranolol for Migraine Prevention

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ClinicalTrials.gov Identifier: NCT00884663
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : December 24, 2013
Sponsor:
Collaborators:
AstraZeneca
St. Olavs Hospital
Kragerø Tablettproduksjon as, Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE April 21, 2009
Last Update Posted Date December 24, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or is treated with the patient's usual headache medication [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
  • Days with headache [ Time Frame: One year ]
  • Hours with headache [ Time Frame: One year ]
  • Headache intensity (0-3 scale) on days with headache [ Time Frame: one year ]
  • Doses of analgesics [ Time Frame: one year ]
  • Doses of triptans [ Time Frame: One year ]
  • Days with sick leave [ Time Frame: one year ]
  • Number of responders (≥ 50% decrease in migraine days compared with baseline) [ Time Frame: one year ]
  • Number of reported side effects [ Time Frame: one year ]
  • Number of predefined retrospective side effects [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Candesartan Versus Propranolol for Migraine Prevention
Official Title  ICMJE Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
Brief Summary The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.
Detailed Description Candesartan was shown to be effective for migraine prophylaxis in a randomized double blind cross-over study published in 2003. The drug is now widely used for this purpose in many countries, although no confirmatory study has been published. The aims of the present study are: 1) to see if the results in the first candesartan study can be replicated in a new patient population, including patients with chronic migraine, and, 2) to perform a head-to-head comparison of candesartan 16 mg/day with standard treatment with propranolol 160 mg slow release. We also intend to study whether responsiveness to these drugs may be related to heart rate variability and baroreceptor sensitivity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine Without Aura
  • Migraine With Aura
  • Chronic Migraine
Intervention  ICMJE
  • Drug: Candesartan
    Candesartan cilexitil tablets, 16 mg once daily
  • Drug: propranolol
    Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
  • Drug: placebo
    placebo tablets and capsules
Study Arms  ICMJE
  • Experimental: 1 Candesartan
    Intervention: Drug: Candesartan
  • Active Comparator: 2 propranolol
    Intervention: Drug: propranolol
  • Placebo Comparator: 3 Placebo
    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 20, 2009)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 18 to 65 years
  • retrospectively have ≥ 2 migraine attacks per month during the last 3 months
  • during the baseline period have ≥ 2 migraine attacks
  • debut of migraine at least one year prior to inclusion
  • start of migraine before age 50 years.

Exclusion Criteria:

  • interval headache not distinguishable from migraine
  • chronic tension-type headache or other headache occurring on ≥ 15 days/month
  • pregnancy, nursing or inability to use contraceptives
  • heart conduction block on ECG or significant ECG abnormality on inclusion
  • heart rate < 54 after 3 minutes rest
  • previous or present asthma, diabetes; decreased hepatic or renal function
  • hypersensitivity to active substance
  • history of angioneurotic edema
  • significant psychiatric illness
  • use of daily migraine prophylactics less than 4 weeks prior to start of study
  • having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
  • previous use of propranolol or candesartan in adequate doses
  • previous discontinuation of either Atacand or Inderal Retard (or another beta blocker) due to side effects
  • current use of antihypertensive medication
  • require use of rizatriptan (Maxalt) 10 mg tabl.
  • subjects requiring detoxification from acute medication (ergotamines, opioids)
  • patients who consistently fail to respond to any acute migraine medication
  • patients with alcohol or illicit drug dependence
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00884663
Other Study ID Numbers  ICMJE 01-47-7006-2008
2008-002312-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
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
  • St. Olavs Hospital
  • Kragerø Tablettproduksjon as, Norway
Investigators  ICMJE
Principal Investigator: Lars J Stovner, Ph.D. Norwegian National Headache Centre, St. Olavs Hospital
Study Director: Lars J Stovner, Ph.D. Norwegian National Headache Centre
PRS Account Norwegian University of Science and Technology
Verification Date December 2013

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