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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
standardized local evaluation of urodynamic parameters
Patients already treated with EG110A
assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Sidney Kimmel Medical College
Philadelphia, Pennsylvania, United States
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas, United States
Incidence of treatment emergent serious adverse events (TESAEs)
Any participant who has a reported treatment emergent serious adverse event (TESAE)
Time frame: 5 years
Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)
Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)
Time frame: 5 years
Patient-reported outcome (PRO) questionnaire
Participantes I-QOL total summary scores throughout the study compared with baseline from EG110A-001-01 study
Time frame: 5 years
Duration of response to EG110A
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
Time frame: 5 years
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