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A 6-Month Extension Study Following Protocol VMALS-002-2 (A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis)

Study Purpose:

The purpose of this study is to evaluate the long-term safety of intramuscular (IM) administration of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS) who were previously randomized, received treatment, and completed the Day 180 Visit of Study VMALS-002-2. Safety will be assessed by incidences of treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and the clinically significant laboratory values. See the table below for additional, exploratory endpoints.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT05176093

Neals Affiliated?

No

Coordinating Center Contact Information


Jennifer Guzman / .(JavaScript must be enabled to view this email address) / 858-428-1225
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

Study Sponsor:

Helixmith Co., Ltd.

Participant Duration:

Estimated Enrollment:

18

Estimated Study Start Date:

11/14/2021

Estimated Study Completion Date:

11/30/2022

Posting Last Modified Date:

01/07/2022

Date Study Added to alsconsortium.org:

01/07/2022
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    • Participants who complete the Day 180 Visit in VMALS-002-2 are eligible to enroll in this extension study, VMALS-002-2b.

    Exclusion Criteria:

    • None

  • Site Contact Information

    Austin Neuromuscular Center
    Michael Chiodo / .(JavaScript must be enabled to view this email address) / 512-920-0140 ext 210
    Austin, Texas 78756
    United States