Spinal Cord Injury, Urinary Bladder, Overactive
Conditions
Brief 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.
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
OTHERUrodynamics
standardized local evaluation of urodynamic parameters
DRUGEG110A
Patients already treated with EG110A
assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms
Sponsors
EG 427
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome (PRO) questionnaire | 5 years | Participantes I-QOL total summary scores throughout the study compared with baseline from EG110A-001-01 study |
| Duration of response to EG110A | 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 |
Countries
United States
Contacts
Primary ContactSandrine Zourbas, Ph.D.
Backup ContactCornelia Haag-Molkenteller, MD
Outcome results
None listed