Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

Trial sites (4)

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