WithdrawnInterventionalPhase 2Last updated Nov 17, 2022

Evaluate PU-AD in Subjects With Amyotrophic Lateral Sclerosis

A Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Biological Activity, Safety, and Pharmacokinetics of PU-AD in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Overview

ClinicalTrials.gov ID: NCT04505358
Lead Sponsor: Samus Therapeutics, Inc.INDUSTRY
Brief Summary: This is a multicenter, Phase 2a, randomized, double-blind, placebo-controlled pilot study to assess the biological activity, safety and pharmacokinetics of PU-AD compared to placebo in ALS. It will be conducted in approximately 20 sites in the US. Approximately 30 subjects will be enrolled in this study; subjects will be randomized 3:2 to receive either PU-AD 30 mg or matching placebo qd, added onto any current stable background treatment.

Status

Overall Status: Withdrawn
Start Date: Jan 2023Estimated
Primary Completion Date: Dec 2024Estimated
Completion Date: Jan 2025Estimated

Study Record Dates

First Submitted: Jul 23, 2020
First Submitted that Met QC Criteria: Aug 5, 2020
First Posted: Aug 10, 2020Actual
Last Update Submitted that Met QC Criteria: Nov 14, 2022
Last Update Posted: Nov 17, 2022Actual
Last Verified: Nov 2022

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