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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received EG110A in a clinical study, regardless of dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urodynamics | Other | standardized local evaluation of urodynamic parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent serious adverse events (TESAEs) | Any participant who has a reported treatment emergent serious adverse event (TESAE) | 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) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome (PRO) questionnaire | Participantes I-QOL total summary scores throughout the study compared with baseline from EG110A-001-01 study | 5 years |
| Duration of response to EG110A |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine Zourbas, Ph.D. | Contact | 33 (0)625622802 | 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 | Downey | California | 90242 | United States |
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| EG110A | Drug | Patients already treated with EG110A |
|
| Patient-reported Outcome | Other | assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms |
|
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
| 5 years |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
|
| Sidney Kimmel Medical College | Philadelphia | Pennsylvania | 19107 | United States |
|
| UTHealth Houston / TIRR Memorial Hermann | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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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| ID | Term |
|---|---|
| D014563 | Urodynamics |
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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