Clinical Trials Directory

Trials / Terminated

TerminatedNCT04475549

Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)

A Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Individuals With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Tisento Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.

Detailed description

IW-6463 tablets will be orally administered once-daily (QD) for up to 29 days

Conditions

Interventions

TypeNameDescription
DRUGIW-6463 TabletsIW-6463 tablets administered orally (daily)

Timeline

Start date
2020-11-13
Primary completion
2022-01-23
Completion
2022-01-23
First posted
2020-07-17
Last updated
2024-08-29
Results posted
2023-11-15

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04475549. Inclusion in this directory is not an endorsement.