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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003386-18 | EudraCT Number | ||
| NFR 288699. | Other Grant/Funding Number | Research Council of Norway |
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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| Nordlandssykehuset HF | OTHER |
| Molde Hospital | OTHER |
| Haukeland University Hospital |
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The main objective of this study is to see whether the favorable preventative effect of candesartan 16 mg per day in episodic migraine, that was found previously in two smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) also a smaller dose of 8 mg is effective, and 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan 8 mg | Experimental |
| |
| Candesartan 16 mg | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan Oral Tablet 8 mg | Drug | 1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in number of migraine days per 4 weeks, from baseline | participants will fill in a headache diary during 20 weeks treatment | 20 weeks plus final visit 1 week after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Samsonsen, md phd | St Olavs Hospital, Dept Neurology & Clinical Neurophysiology | Study Director |
| Jorunn L Helbostad, prof | Norwegian University of Science and Technology, Fac MH, Dept INB | Study Director |
| Erling Tronvik, md prof | Norwegian University of Science and Technology, Fac MH, Dept INB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Clinics | Tartu | Estonia | ||||
| Haukeland University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40975098 | Derived | Oie LR, Wergeland T, Salvesen O, Gravdahl GRB, Aschehoug I, Gulati S, Bj Rk MH, Lundqvist C, Alstadhaug KBR, Winsvold BS, Aamodt AH, Larsen IC, B E MG, Braschinsky M, Muller B, Vetvik KGT, Muller KI, Aaseth K, Khanevski AN, Ovrevik AB, Vegrim HM, Lindroos J, Eid K, Engstrand H, Bezgal B, Larsen MB, Osthus JHG, Stovner LJ, Tronvik E. Candesartan versus placebo for migraine prevention in patients with episodic migraine: a randomised, triple-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2025 Oct;24(10):817-827. doi: 10.1016/S1474-4422(25)00269-8. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C081643 | candesartan |
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| OTHER |
| Sorlandet Hospital HF | OTHER_GOV |
| University Hospital, Akershus | OTHER |
| Ullevaal University Hospital | OTHER |
| Rikshospitalet University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Tartu University Hospital | OTHER |
A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses
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| Candesartan Oral Tablet 16 mg | Drug | 1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days). |
|
| Placebo oral tablet | Drug | 1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days). |
|
| Bergen |
| Norway |
| Nordland Hospital | Bodø | Norway |
| Sørlandet Hospital | Kristiansand | Norway |
| Akershus University Hospital AHUS | Lørenskog | Norway |
| Møre and Romsdal Hospital Molde | Molde | Norway |
| Rikshospitalet University Hospital | Oslo | Norway |
| Ullevål University Hospital | Oslo | Norway |
| University Hospital of North Norway | Tromsø | Norway |
| St Olavs Hospital | Trondheim | Norway |
| D009422 | Nervous System Diseases |