Urodynamics: standardized local evaluation of urodynamic parameters
EG110A: Patients already treated with EG110A
Patient-reported Outcome: assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
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
Primary outcome measure(s)
Incidence of treatment emergent serious adverse events (TESAEs) — 5 years Any participant who has a reported treatment emergent serious adverse event (TESAE)
Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs) — 5 years Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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