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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252510505_CDMRP | Other Grant/Funding Number | US Department of Defense |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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.
This first-in-human clinical study, performed in SCI participants with Urinary Incontinence (UI) due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EG110A (low dose) | Experimental | Patients who Received EG110A (low dose) |
|
| EG110A (Middle Dose) | Experimental | Patients who Received EG110A (middle dose) |
|
| EG110A (High Dose) | Experimental | Patients who Received EG110A (high dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG110A | Drug | Participants treated with EG110A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Any participant who has a reported treatment-emergent adverse events (TEAEs) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Urodynamic variables: changes at Weeks 12 and 52 compared to baseline | Changes in urodynamic variables will be assessed at Weeks 12 and 52. | 1 year |
| Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline |
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Main Inclusion Criteria:
Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening.
Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.
Participant has:
been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT/A treatment, and their next step would be surgical intervention.
OR
had an inadequate response to BoNT/A treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT/A treatment for their NDO was at least 6 months prior to screening. Treatment with BoNT/A was not started more than 7 years ago, and their next step would be surgical intervention.
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine Zourbas, Ph.D. | Contact | 33 (0)6 25 62 28 02 | szourbas@eg427.com | |
| Cornelia Haag-Molkenteller, MD | Contact | Cornelia@eg427.com |
| Name | Affiliation | Role |
|---|---|---|
| Cornelia Haag-Molkenteller, MD | EG 427 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center | Recruiting | Downey | California | 90242 | United States |
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| Label | URL |
|---|---|
| Learn more about the clinical study EG110A-001-01 | View source |
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This first-in-human clinical study, performed in SCI participants with UI due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.
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7 day bladder diary with recording of urinary incontinence episodes, daily catheterization rates, and volume per catheterization. |
| 1 year |
| University of Michigan Rogel Cancer Center | Withdrawn | Ann Arbor | Michigan | 48109 | United States |
| Sidney Kimmel Medical College | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UTHealth Houston / TIRR Memorial Hermann | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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