What this study is
The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.
What's being tested
- Urodynamics
Intervention · OTHER
standardized local evaluation of urodynamic parameters
- EG110A
Intervention · DRUG
Patients already treated with EG110A
- Patient-reported Outcome
Intervention · OTHER
assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms
Study details
- Official title
- Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy Expressing a Transgene Encoding the Light Chain of Botulinum Toxin F
- Sponsor
- EG 427
- Conditions
- Urinary Bladder, Overactive · Spinal Cord Injury
- Enrolling
- 16 people
- Starts
- 2026-04
- Est. completion
- 2031-04
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.
You can't join if
- Participant plans to participate in another investigational gene therapy study
- Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openRancho Los Amigos National Rehabilitation Center
Downey, California, United States
- Evgeniy Kreydin, MD · Contact
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
- John Stoffel, MD · Contact
Sidney Kimmel Medical College
Philadelphia, Pennsylvania, United States
- Patrick Shenot, MD · Contact
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas, United States
- Argyrios Stampas, MD · Contact
Study team
Sponsor
EG 427
Study ID EG110A-001-02
Study director
Cornelia Haag-Molkenteller, MD
EG 427
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.