Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

Part of paid clinical trials in Downey, California.

Sponsor
EG 427
Study ID
NCT06596291
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Neurogenic Detrusor Overactivity
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • EG110A — DRUG
    Participants treated with EG110A

Study Details

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.

Key Dates

First listed
Sep 19, 2024
Start date
Jan 8, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EG110A (low dose)
    Patients who Received EG110A (low dose)
  • Experimental: EG110A (Middle Dose)
    Patients who Received EG110A (middle dose)
  • Experimental: EG110A (High Dose)
    Patients who Received EG110A (high dose)

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Rancho Los Amigos National Rehabilitation CenterDowneyCalifornia90242
Evgeniy Kreydin, MD
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Sidney Kimmel Medical CollegePhiladelphiaPennsylvania19107
Patrick Shenot, MD
UTHealth Houston / TIRR Memorial HermannHoustonTexas77030
Argyrios Stampas, MD

Find similar trials in Downey, CA

By research site
Rancho Los Amigos National Rehabilitation Center· Downey, CAUniversity of Michigan Rogel Cancer Center· Ann Arbor, MISidney Kimmel Medical College· Philadelphia, PAUTHealth Houston / TIRR Memorial Hermann· Houston, TX

Related Studies