Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Not authorised
Participants planned
450
Countries
1
Sites
5
Migraine
To evaluate whether the favourable preventative effect ofAtorvastin in two different doses seen in three smaller studies, can be confirmed in a larger multicentre randomized, controlled study
Key facts
- Sponsor
- St. Olavs Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2023-03-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- NTNU NorHead
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Dose response, Safety, Prophylaxis
To evaluate whether the favourable preventative effect ofAtorvastin in two different doses seen in three smaller studies, can be confirmed in a larger multicentre randomized, controlled study
Secondary objectives 1
- Number of responders and evaluations of side effects
Conditions and MedDRA coding
Migraine
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Aged 18 to 65 years with 4-14 migraine days per month
- Signed informed consent
- Episodic migraine with or without aura according to ICHD-3 criteria, debut of migraine at least one year prior to inclusion, and start of migraine before age 50 years
- No use of other migraine prophylactics during the study
- For women of child-bearing potential there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception
Exclusion criteria 7
- Interval headache not distinguishable from migraine or chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month.
- Pregnancy, planning to get pregnant, inability to use contraceptives or lactating.
- Clinical information on signs of cholestasis, decreased hepatic or renal function, high degree of comorbidity, frailty associated with reduced life expectancy, high likelihood of hospitalization at the discretion of the investigator,, history of angioneurotic oedema, current use of antiviral treatment against hepatitis C, significant psychiatric illness, alcohol or illicit drug dependence, inability to understand study procedures and to comply with them for the entire length of the study, and/or treatment for hypothyroidism
- Hypersensitivity to statins or previous use of statins
- Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
- Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
- Consistently failing to respond to any acute migraine medication and/or requiring detoxification from acute medication (triptans, opioids)
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 headache per 4 weeks
- Difference in change from baseline between groups receiving atorvastatin 20 mg daily and placebo in number of days with headache per 4 weeks,
- Number of responders (≥ 50% decrease in migraine days compared with baseline) between repectively Atorvastin 40 mg, Atorvastatin 20 mg and placebo
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Atorvastatin Pensa 20 mg filmdrasjerte tabletter
PRD9579707 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- 08-6474
- MA holder
- PENSA PHARMA AB
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Atorvastatin Pensa 40 mg filmdrasjerte tabletter
PRD9579708 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- 08-6475
- MA holder
- PENSA PHARMA AB
- MA country
- Norway
- 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
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Not authorised | 450 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Akershus University Hospital
Neurology, Sykehusveien 25, 1474, Lørenskog
Oslo University Hospital Hf
Neurology, Taarnbygget, Kirkeveien 166, Oslo
St. Olavs Hospital HF
Neurology, P. O. Box 3250, Torgarden, Trondheim
Helse Bergen HF
Neurology, Jonas Lies Vei 65, 5021, Bergen
University Hospital Of North Norway HF
Neurology, P. O. Box 100, 9038, Tromsoe
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-10 | Norway | Acceptable with conditions 2023-02-27
|
2023-03-03 |