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

NCT04102995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2021-07-26

No results posted yet for this study

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.

Conditions

  • Menstrual Migraine

Interventions

DRUG

Sepranolone injection low dose

Subcutaneous (SC) administration

DRUG

Sepranolone injection high dose

Subcutaneous (SC) administration

DRUG

Placebo injection

Subcutaneous (SC) administration

Sponsors & Collaborators

  • Aurevia

    collaborator INDUSTRY

  • Asarina Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2021-05-15
Completion
2021-05-15
FDA Drug
Yes

Countries

  • Finland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04102995 on ClinicalTrials.gov