Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)

  • STATUS
    Recruiting
  • End date
    Aug 30, 2022
  • participants needed
    42
  • sponsor
    Clene Nanomedicine
Updated on 30 July 2021
primary lateral sclerosis
riluzole

Summary

The objective of this trial is to assess the efficacy, safety, and PK/PD effects of CNM-Au8 as a disease-modifying agent for the treatment of ALS by utilizing electrophysiological measures to detect preservation of motor neuron function. The primary endpoint is the mean change in the average difference between active treatment and placebo from Baseline through Week 36 evaluated by electromyography.

Description

This is a multi-centre randomized, double-blind, parallel group, placebo-controlled study of the efficacy, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who are newly symptomatic within 24-months of Screening and with a clinically probable or possible or definite ALS diagnosis per the Awaji-Shima criteria.

Patients may be screened over up to a 6-week period. Patients who meet the inclusion criteria and none of the exclusionary criteria will be enrolled into the clinical study. Patients will be randomized 1:1 into one of two groups: either active treatment with CNM-Au8 30 mg or Placebo.

All patients will receive their randomized oral treatment daily over thirty-six (36) consecutive weeks during the Treatment Period.

There will be up to four study periods:

  1. Up to a six (6) week screening period (Screening Period);
  2. A thirty-six (36) week blinded randomized treatment period (Treatment Period);
  3. Up to a forty-eight (48) week optional open-label extension period (Open-Label Period);
  4. A four (4) week safety follow-up period following completion of either the Treatment or Open-Label period or in the case of Early Termination (Safety Follow-Up Period).

Per protocol, all patients will receive their blinded and randomized oral treatment daily over at least 36 consecutive weeks during the Treatment Period.

For those patients not transitioning into the optional OLE period, patients will complete a safety follow-up visit 4-weeks following study drug discontinuation.

An independent DSMB will be responsible for monitoring the safety of the study on a quarterly basis and ad hoc at the request of the DSMB or the Sponsor (e.g., in the event of unexpected SAEs) to review data throughout the Treatment Period. The DSMB may make recommendations on the conduct of the study, including study termination. Appropriate procedures will be detailed in a DSMB Charter.

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, lou gehrig's disease
Treatment Placebo, CNM-Au8
Clinical Study IdentifierNCT04098406
SponsorClene Nanomedicine
Last Modified on30 July 2021

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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