A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 13 February 2023
• Main ID: NCT05176093
• Date of registration: 05/11/2021
• Prospective Registration: Yes
• Primary sponsor: Helixmith Co., Ltd.
• Public title: A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis REViVALS-1B
• Scientific title: 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)
• Date of first enrolment: November 14, 2021
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05176093
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Biological: Engensis

Other: Placebo

Primary Outcome(s)

• To evaluate the long-term safety of intramuscular (IM) injections of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS) [Time Frame: Day 0 to Day 365]

Secondary ID(s)

VMALS-002-2b

Source(s) of Monetary Support

Please refer to primary and secondary sponsors