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.

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:

Biological, N/A

Intervention Name:

Engensis, Placebo




Phase 2

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


Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

United States

Study Sponsor:

Helixmith Co., Ltd.

Estimated Enrollment:


Estimated Study Start Date:

11 / 14 / 2021

Estimated Study Completion Date:

12 / 29 / 2022

Posting Last Modified Date:

02 / 02 / 2023

Date Study Added to neals.org:

01 / 04 / 2022

Minimum Age:

18 Years

Maximum Age:

80 Years

Can participants use Riluzole?


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

Austin Neuromuscular Center

Austin, Texas 78759
United States

Hanyang University Medical Center

Seoul 04763
Korea, Republic of