NCT00884663

Brief Summary

The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Typical duration 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

April 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

2.9 years

First QC Date

April 20, 2009

Last Update Submit

December 22, 2013

Conditions

Migraine Without AuraMigraine With AuraChronic Migraine

Outcome Measures

Primary Outcomes (1)

  • 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

    One year

Secondary Outcomes (9)

  • Days with headache

    One year

  • Hours with headache

    One year

  • Headache intensity (0-3 scale) on days with headache

    one year

  • Doses of analgesics

    one year

  • Doses of triptans

    One year

  • +4 more secondary outcomes

Study Arms (3)

1 Candesartan

EXPERIMENTAL
Drug: Candesartan

2 propranolol

ACTIVE COMPARATOR
Drug: propranolol

3 Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

CandesartanDRUG

Candesartan cilexitil tablets, 16 mg once daily

1 Candesartan
propranololDRUG

Propranolol hydrochloride capsules 160 mg once daily, slow release formulation

2 propranolol
placeboDRUG

placebo tablets and capsules

3 Placebo

Eligibility Criteria

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

You may qualify if:

  • 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
  • start of migraine before age 50 years.

You may not qualify if:

  • 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 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian National Headache Centre, St. Olavs University Hospital

Trondheim, 7489, 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

  • Stovner LJ, Linde M, Gravdahl GB, Tronvik E, Aamodt AH, Sand T, Hagen K. A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study. Cephalalgia. 2014 Jun;34(7):523-32. doi: 10.1177/0333102413515348. Epub 2013 Dec 11.

    PMID: 24335848RESULT

MeSH Terms

Conditions

Migraine without AuraMigraine with Aura

Interventions

candesartanPropranolol

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Lars J Stovner, Ph.D.

    Norwegian National Headache Centre, St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

  • Lars J Stovner, Ph.D.

    Norwegian National Headache Centre

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

NO(1)