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
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Biological, N/A
Intervention Name:
Engensis, Placebo
Placebo:
Yes
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
United States
Study Sponsor:
Helixmith Co., Ltd.
Estimated Enrollment:
18
Estimated Study Start Date:
11 / 14 / 2021
Estimated Study Completion Date:
02 / 01 / 2023
Posting Last Modified Date:
11 / 07 / 2022
Date Study Added to neals.org:
01 / 04 / 2022
Minimum Age:
18 Years
Maximum Age:
80 Years
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
Austin Neuromuscular Center
Austin, Texas
78759
United States
Hanyang University Medical Center
Seoul 04763
Korea, Republic of