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

NCT ID: NCT07227285

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2031-04-30

Brief Summary

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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

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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

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Urinary Bladder, Overactive Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients who received EG110A in a clinical study, regardless of dose

Group Type EXPERIMENTAL

Urodynamics

Intervention Type OTHER

standardized local evaluation of urodynamic parameters

EG110A

Intervention Type DRUG

Patients already treated with EG110A

Patient-reported Outcome

Intervention Type OTHER

assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms

Interventions

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Urodynamics

standardized local evaluation of urodynamic parameters

Intervention Type OTHER

EG110A

Patients already treated with EG110A

Intervention Type DRUG

Patient-reported Outcome

assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EG 427

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cornelia Haag-Molkenteller, MD

Role: STUDY_DIRECTOR

EG 427

Locations

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Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Site Status

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Sidney Kimmel Medical College

Philadelphia, Pennsylvania, United States

Site Status

UTHealth Houston / TIRR Memorial Hermann

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Sandrine Zourbas, Ph.D.

Role: CONTACT

Phone: 33 (0)625622802

Email: [email protected]

Cornelia Haag-Molkenteller, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Evgeniy Kreydin, MD

Role: primary

John Stoffel, MD

Role: primary

Patrick Shenot, MD

Role: primary

Argyrios Stampas, MD

Role: primary

Other Identifiers

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EG110A-001-02

Identifier Type: -

Identifier Source: org_study_id