A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine

Menstrual Migraine Clinical Trial

— APH204  

Official title:

An Exploratory Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102995
• Other study ID #: APH204
• Status: Completed
• Phase: Phase 2
• Start date: August 27, 2019
• Est. completion date: May 15, 2021

Study information

• Verified date: July 2021
• Source: Asarina Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 between Day -2 and Day 5 of the menstrual cycle. Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two week preceding the menstruation for three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using an electronic diary using validated scales for assessment of menstual migraine symptoms.

Sepranolone is identical to an endogenous steroid.

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 occurring between Day -2 and Day 5 of the menstrual cycle in comparison to placebo. Study treatment will be self-administrated as subcutaneous injections during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using an electronic migraine diary and a validated rating scale for assessment the physical and functional impact of menstrual migraine symptoms (MPFID). Preceding the treatment period, the diagnosis of Menstrual Migraine will be established by verifying menstrual migraine in at least two out of three menstrual cycles of daily symptom ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The reduction in average number of menstrual migraine days per menstrual cycle during the treatment period cycles vs. the three menstrual cycles of baseline will constitute the primary endpoint.

The study will also include a follow-up (no treatment) cycle before patients final visit.

The study is conducted in three European countries (Sweden, Finland and Denmark) and will randomize 84 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Menstrual Migraine
• Migraine Disorders
• Premenstrual Syndrome

Intervention

Drug:
• Sepranolone injection low dose
Subcutaneous (SC) administration
• Sepranolone injection high dose
Subcutaneous (SC) administration
• Placebo injection
Subcutaneous (SC) administration

Locations

Country	Name	City	State
Finland	Suomen Terveystalo Plc	Helsinki
Finland	Suomen Terveystalo Plc	Tampere
Finland	Suomen Terveystalo Plc	Turku
Sweden	CTC Clinical Trial Center	Gothenburg
Sweden	ProbarE i Lund	Lund	Skane
Sweden	Karolinska Trial Alliance	Stockholm
Sweden	CTC Clinical Trial Consultants	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Asarina Pharma	Scandinavian CRO

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of menstrual migraine days	Change from baseline in the average number of menstrual migraine days during three consecutive menstrual cycles	Through study completion, an average of 6 months