Migraine Without AuraPhase 2/3NCT00884663
Candesartan Versus Propranolol for Migraine Prevention
A Phase 2/3 study testing Candesartan and propranolol in people with Migraine Without Aura and Migraine With Aura, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Without Aura, Migraine With Aura, Chronic Migraine
- What is being tested?
- Candesartan and propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2009to Mar 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian National Headache Centre, St. Olavs University Hospital
Trondheim, 7489
About this study
Official title: Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.
Read the 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.
- Conditions
- Migraine Without Aura, Migraine With Aura, Chronic Migraine
- Being tested
- Candesartan, propranolol, placebo
- Medical subject headings
- Migraine without Aura, Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Candesartan cilexitil tablets, 16 mg once daily
propranololDrug
Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
placeboDrug
placebo tablets and capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 Candesartan | Experimental | Not described Receives: Drug: Candesartan |
| 2 propranolol | Active comparator | Not described Receives: Drug: propranolol |
| 3 Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (9)
Days with headache
Measured: One year
Hours with headache
Measured: One year
Headache intensity (0-3 scale) on days with headache
Measured: one year
Doses of analgesics
Measured: one year
Doses of triptans
Measured: One year
Days with sick leave
Measured: one year
Number of responders (≥ 50% decrease in migraine days compared with baseline)
Measured: one year
Number of reported side effects
Measured: one year
Number of predefined retrospective side effects
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, St. Olavs Hospital, Kragerø Tablettproduksjon as, Norway
- Responsible party
- Sponsor
- Investigators
- Lars J Stovner, Ph.D., Principal investigator, Norwegian National Headache Centre, St. Olavs HospitalLars J Stovner, Ph.D., Study director, Norwegian National Headache Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884663
- Sponsor's protocol ID
- 01-47-7006-2008
- Other IDs
- 2008-002312-17, 2008
- Status last verified
- Dec 2013
- First submitted
- 20 Apr 2009
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12503978Stovner 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.
PubMed 24335848
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
- ClinicalTrials.gov ID
- NCT00884663
- Acronym / sponsor ID
- 01-47-7006-2008
- Conditions
- Migraine Without Aura, Migraine With Aura, Chronic Migraine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- AstraZeneca, St. Olavs Hospital, Kragerø Tablettproduksjon as, Norway
- Study start
- Apr 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Candesartan | Experimental | Drug: Candesartan |
| 2 propranolol | Active comparator | Drug: propranolol |
| 3 Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CandesartanCandesartan cilexitil tablets, 16 mg once daily | Drug | 1 Candesartan |
| propranololPropranolol hydrochloride capsules 160 mg once daily, slow release formulation | Drug | 2 propranolol |
| placeboplacebo tablets and capsules | Drug | 3 Placebo |
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Background: PubMed 12503978Tronvik 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.
- Results publication: PubMed 24335848Stovner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars J Stovner, Ph.D. principal investigator
Norwegian National Headache Centre, St. Olavs Hospital
Lars J Stovner, Ph.D. study director
Norwegian National Headache Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Candesartan and propranolol in people with Migraine Without Aura and Migraine With Aura, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884663, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.