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Safety, Blood Levels and Effects of AUT00201 in Patients With MEAK

NCT05873062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-03-25

Study results available
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Summary

A randomized, double-blind, placebo-controlled, crossover study to assess the safety, tolerability, and pharmacokinetics of single doses of AUT00201 at 100 mg or matching placebo in patients with myoclonus epilepsy and ataxia due to potassium channel mutation (MEAK).

Conditions

  • Myoclonus Epilepsies, Progressive

Interventions

DRUG

AUT00201

Single oral dose

DRUG

Placebo

Single oral dose

Sponsors & Collaborators

  • Autifony Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Michael Gelfand, MD · Penn Epilepsy Center, Department of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2024-05-01
Completion
2024-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05873062 on ClinicalTrials.gov