Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy
NCT07227285 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-11-12
Summary
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.
Conditions
- Urinary Bladder, Overactive
- Spinal Cord Injury
Interventions
- OTHER
-
Urodynamics
standardized local evaluation of urodynamic parameters
- DRUG
-
EG110A
Patients already treated with EG110A
- OTHER
-
Patient-reported Outcome
assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms
Sponsors & Collaborators
-
EG 427
lead INDUSTRY
Principal Investigators
-
Cornelia Haag-Molkenteller, MD · EG 427
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2031-04-30
- Completion
- 2031-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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