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Evaluate PU-AD in Subjects With Amyotrophic Lateral Sclerosis

NCT04505358 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-11-17

No results posted yet for this study

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.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

PU-AD

active vs placebo

DRUG

Placebo

active vs placebo

Sponsors & Collaborators

  • Samus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Silverman, MD · Samus Therapeutics Consultant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-12-31
Completion
2025-01-31
FDA Drug
Yes

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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 NCT04505358 on ClinicalTrials.gov