A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine (APH204)

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

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Migraine
• Intervention / Treatment: Drug: Sepranolone injection low dose; Drug: Sepranolone injection high dose; Drug: Placebo injection

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 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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Suomen Terveystalo Plc
  • Tampere, Finland
    • Suomen Terveystalo Plc
  • Turku, Finland
    • Suomen Terveystalo Plc
• Sweden
  • Gothenburg, Sweden
    • CTC Clinical Trial Center
  • Stockholm, Sweden
    • Karolinska Trial Alliance
  • Uppsala, Sweden
    • CTC Clinical Trial Consultants
  • Skane
    • Lund, Skane, Sweden, 22222
      • ProbarE i Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sepranolone (UC1010) low dose; Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine	Drug: Sepranolone injection low dose; Subcutaneous (SC) administration; Other Names: UC1010
Experimental: Sepranolone (UC1010) high dose; Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine	Drug: Sepranolone injection high dose; Subcutaneous (SC) administration; Other Names: UC1010
Placebo Comparator: Placebo; Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine	Drug: Placebo injection; Subcutaneous (SC) administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Asarina Pharma
• Collaborators: Scandinavian CRO

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Menstruation Disturbances; Migraine Disorders; Premenstrual Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Pregnanolone
• Other Study ID Numbers: APH204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No