Actively Recruiting
Safety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis
Led by Celosia Therapeutics Pty Ltd · Updated on 2026-02-10
15
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
C
Celosia Therapeutics Pty Ltd
Lead Sponsor
N
Novotech (Australia) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study is in participants with Amyotrophic Lateral Sclerosis and is designed to evaluate the safety and tolerability of the gene therapy CTx1000.
CONDITIONS
Official Title
Safety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ALS by revised El Escorial criteria and TRICALS risk score
- Disease duration of 2 years or less since first symptoms
- No or low anti-AAV9 antibodies (titre 1:50 or less)
- Stable use of standard ALS medications such as riluzole or edaravone for at least 30 days before screening
- Not pregnant or breastfeeding, or willing to stop breastfeeding
- Use of barrier contraception methods by all participants
You will not qualify if you...
- Genetic forms of ALS except for TARDBP gene variants
- History of heart attack or stroke within 6 months before screening
- Uncontrolled diabetes with HbA1C greater than 9%
- Positive tests for cytomegalovirus, hepatitis C, hepatitis B, or HIV
- Poor organ function
- Current open tracheostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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