Status:
COMPLETED
A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine
Lead Sponsor:
Asarina Pharma
Collaborating Sponsors:
Aurevia
Conditions:
Menstrual Migraine
Eligibility:
FEMALE
18-48 years
Phase:
PHASE2
Brief Summary
The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring betw...
Detailed Description
The objective of this phase 2 Proof-of-Concept study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occ...
Eligibility Criteria
Inclusion
- have Menstrual Migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) verified in three menstrual cycles
- have a regular menstrual cycle of 24-35 days cycle,
- use double barrier contraception, intrauterine device (IUD), be truly sexually abstinent, or subject or her partner has been surgically sterilized,
Exclusion
- More than 10 headache days per month on average during screening phase
- steroid hormonal treatment during previous three months
- ongoing treatment with antiepileptic drugs or benzodiazepines
- significant medical or psychiatric condition
- be pregnant or plan a pregnancy within the study period
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2021
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04102995
Start Date
August 27 2019
End Date
May 15 2021
Last Update
July 26 2021
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Suomen Terveystalo Plc
Helsinki, Finland
2
Suomen Terveystalo Plc
Tampere, Finland
3
Suomen Terveystalo Plc
Turku, Finland
4
ProbarE i Lund
Lund, Skåne County, Sweden, 22222