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NCT Number: NCT07227285

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

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.

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Key information

Conditions

Urinary Bladder, Overactive Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rancho Los Amigos National Rehabilitation Center, Downey, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urodynamics

Other

standardized local evaluation of urodynamic parameters

EG110A

Drug

Patients already treated with EG110A

patient-reported outcome

Other

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

Primary outcomes

  1. Incidence of treatment emergent serious adverse events (TESAEs)

    Time frame: 5 years

    Any participant who has a reported treatment emergent serious adverse event (TESAE)

  2. Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)

    Time frame: 5 years

    Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)

Secondary outcomes

  1. Patient-reported outcome (PRO) questionnaire

    Time frame: 5 years

    Participantes I-QOL total summary scores throughout the study compared with baseline from EG110A-001-01 study

  2. Duration of response to EG110A

    Time frame: 5 years

    Time from initial treatment with EG110A to request an alternative treatment for NDO by the participant at any time during the long-term follow-up study

Study contacts

Contact information is provided by the study sponsor or research team.

Cornelia Haag-Molkenteller, MD

CONTACT

[email protected]

Sandrine Zourbas, Ph.D.

CONTACT

[email protected]

33 (0)625622802

Sponsors and collaborators

Lead sponsor

Cyllene Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Nov 12, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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