Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
6
Chronic migraine
To evaluate whether the favourable preventative effect of Atorvastin in three smaller studies in episodic migraine, can be confirmed in a larger multicentre randomized, controlled chronic migraine study
Key facts
- Sponsor
- St. Olavs Hospital HF, St. Olavs Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 13 May 2024 → ongoing
- Decision date (initial)
- 2023-06-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- NorHead, NTNU
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Prophylaxis, Efficacy
To evaluate whether the favourable preventative effect of Atorvastin in three smaller studies in episodic migraine, can be confirmed in a larger multicentre randomized, controlled chronic migraine study
Secondary objectives 1
- To evaluate number of responders and side effects
Conditions and MedDRA coding
Chronic migraine
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Drug intervention It will be a multicentre, randomized, triple blind (blinded
patients, study personnel, and statistician), parallel group study, comparing Atorvastin 40 mg against placebo. There will be four Norwegian Centre. Altogether, 300 patients with chronic migraine will be included. The primary endpoint is change in number of migraine days/4 weeks from the baseline period to the treatment period. Secondary endpoints are number of responders (≥ 50% improvement from baseline), number of patients with adverse events, doses of triptans or analgesics per 4 weeks, and days with sick leave per 4 weeks.
|
Randomised Controlled | Double | [{"id":66331,"code":4,"name":"Analyst"},{"id":66329,"code":1,"name":"Subject"},{"id":66330,"code":2,"name":"Investigator"}] | Placebo: 1 tablet per day in 12 week Atrovastatin: 1 tablet per day in 12 weeks |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Unidenfied Datafile will be avaialble
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-502177-42-00 | A multicentre, triple blind, placebo controlled, parallel group study of atorvastatin in chronic migraine | St. Olavs Hospital HF |
| 2022-502177-42-01 | A multicentre, triple blind, placebo controlled, parallel group study of atorvastatin in chronic migraine | St. Olavs Hospital HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Age 18 to 65 years
- Signed informed consent
- Chronic migraine according to ICHD-3 criteria
- At inclusion, patients should retrospectively have at least 15 headache days per month wheof at least 8 migraine days during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment
- Debut of migraine at least one year prior to inclusion
- Start of migraine before age 50 years.
- No use of other migraine prophylactics during the study
- For women of child-bearing potential (WOCBP, see below) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception
Exclusion criteria 9
- Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling having tried a withdrawal period of at least 2 months without impact on headache frequency and use of opiods (of any type) ≤ 8 days /months.
- Pregnancy, planning to get pregnant, inability to use contraceptives and lactating
- Clinical information on or signs of cholestasis or decreased hepatic or renal function
- High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
- Hypersensitivity to statins or previous use of statins or lactose intolerance
- History of angioneurotic oedema, current use of antiviral treatment agaist hepatitis C, and/or treatment for hypothyroidism
- Significant psychiatric illness and/or alcohol or illicit drug dependence
- Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
- Inability to understand study procedures and to comply with them for the entire length of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference between groups receiving atorvastatin 40 mg daily and placebo in change from baseline in number of migraine days per 4 weeks
Secondary endpoints 3
- Difference between groups receiving atorvastatin 40 mg daily and placebo in change from baseline in number of days with headache
- Number of reported side effects in the placebo and atorvastatin 40 mg
- Comparison of cost in the placebo and atorvastatin treatment, taking into consideration price of the medicine, price of acute medication, and lost worktime
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1010304 · ATC
- Active substance
- Atorvastatin
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 84
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1
- Max total dose
- 84
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St. Olavs Hospital HF
- Sponsor organisation
- St. Olavs Hospital HF
- Address
- Prinsesse Kristinas G. 3
- City
- Trondheim
- Postcode
- 7030
- Country
- Norway
Scientific contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Knut Hagen
Public contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Knut Hagen
St. Olavs Hospital HF
- Sponsor organisation
- St. Olavs Hospital HF
- Address
- P. O. Box 3250, Torgarden Torgarden
- City
- Trondheim
- Postcode
- 7006
- Country
- Norway
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 300 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
St. Olavs Hospital HF
Neurology, P. O. Box 3250, Torgarden, Trondheim
Oslo University Hospital Hf
Neurology, P. O. Box 4953, 0424, Oslo
Oslo University Hospital Hf
Neurology, Sognsvannsveien 20, 0372, Oslo
Akershus University Hospital
Neurology, Sykehusveien 27, 1478, Lorenskog
Helse Bergen HF
Neurology, P. O. Box 1400, 5021, Bergen
Universitetssykehuset Nord-Norge HF
Neurology, P. O. Box 100, 9038, Tromsoe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2024-05-13 | 2024-05-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1 Recruitement arrangements without track changes | 3 |
| Recruitment arrangements (for publication) | K2_Recruitement arrangement material 2022-502177-42-02 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2022-502177-42-02 with trach changes | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 502177-42-02 Public | 6 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-22 | Norway | Acceptable 2023-06-20
|
2023-06-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-04 | Norway | Acceptable 2023-06-20
|
2023-09-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-19 | Norway | Acceptable 2023-11-03
|
2023-11-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-12 | Norway | Acceptable 2024-03-18
|
2024-03-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-12 | Norway | Acceptable 2024-03-18
|
2024-04-12 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-05-07 | Norway | Acceptable 2024-03-18
|
2024-05-07 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-06-12 | Norway | Acceptable 2024-03-18
|
2024-06-12 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-06-20 | Norway | Acceptable 2024-03-18
|
2024-06-20 |