Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urodynamics, EG110A, Patient-reported Outcome.
- Who it may be relevant to
- Registry conditions: Urinary Bladder, Overactive, Spinal Cord Injury. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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
Primary outcome measures
- Incidence of treatment emergent serious adverse events (TESAEs) [Time frame: 5 years]
- Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs) [Time frame: 5 years]
Secondary outcome measures (2)
- Patient-reported outcome (PRO) questionnaire [Time frame: 5 years]
- Duration of response to EG110A [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 4 centers
- Rancho Los Amigos National Rehabilitation Center — Downey
- University of Michigan Rogel Cancer Center — Ann Arbor
- Sidney Kimmel Medical College — Philadelphia
- UTHealth Houston / TIRR Memorial Hermann — Houston
Identifiers
NCT: NCT07227285 · EG110A-001-02