NCT04102995

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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2019

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

September 23, 2019

Last Update Submit

July 22, 2021

Conditions

Menstrual Migraine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Sepranolone (UC1010) low dose

EXPERIMENTAL

Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine

Drug: Sepranolone injection low dose

Sepranolone (UC1010) high dose

EXPERIMENTAL

Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine

Drug: Sepranolone injection high dose

Placebo

PLACEBO COMPARATOR

Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine

Drug: Placebo injection

Interventions

Sepranolone injection low doseDRUG

Subcutaneous (SC) administration

Also known as: UC1010
Sepranolone (UC1010) low dose
Sepranolone injection high doseDRUG

Subcutaneous (SC) administration

Also known as: UC1010
Sepranolone (UC1010) high dose
Placebo injectionDRUG

Subcutaneous (SC) administration

Placebo

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Suomen Terveystalo Plc

Helsinki, Finland

Location

Suomen Terveystalo Plc

Tampere, Finland

Location

Suomen Terveystalo Plc

Turku, Finland

Location

ProbarE i Lund

Lund, Skåne County, 22222, Sweden

Location

CTC Clinical Trial Center

Gothenburg, Sweden

Location

Karolinska Trial Alliance

Stockholm, Sweden

Location

CTC Clinical Trial Consultants

Uppsala, Sweden

Location

MeSH Terms

Interventions

Pregnanolone

Intervention Hierarchy (Ancestors)

PregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

August 27, 2019

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(4)FI(3)