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
EG 427
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.
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 pop…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- OtherUrodynamics
standardized local evaluation of urodynamic parameters
- DrugEG110A
Patients already treated with EG110A
- OtherPatient-reported Outcome
assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms
Locations (4)
- Rancho Los Amigos National Rehabilitation CenterDowney, California
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan
- Sidney Kimmel Medical CollegePhiladelphia, Pennsylvania
- UTHealth Houston / TIRR Memorial HermannHouston, Texas