NCT07227285

Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: EG 427 · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this long-term follow-up study is to continue following participants who have received EG110A for safety, and to observe long-term efficacy via a disease-specific quality of life questionnaire, time to participant request for alternative treatment, and locally-evaluated urodynamics. This study aims to identify any potential long-term risks and will capture any delayed adverse events (AEs) in participants following the last study visit of the preceding study. Additionally, it will allow the Sponsor to further understand the long-term effectiveness of EG110A in this patient population.

Conditions

• Urinary Bladder, Overactive
• Spinal Cord Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2025-11-12
• Last updated: 2025-11-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study