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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514303-34-00 | EU Trial (CTIS) Number |
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This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NG004 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NG004 | Drug | repeated intrathecal injections of NG004 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions | From treatment start up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] in serum | After first and last intrathecal injection, measured at pre-dose and 1, 3, 6, 24, 48 hours post-dose. | |
| Half-life in serum [T1/2] | After last intrathecal injection up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on motor function as Change from Baseline in ISNCSCI upper extremities motor score (UEMS), according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol | The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Contact | +41433005263 | clinical@novagotx.com |
| Name | Affiliation | Role |
|---|---|---|
| Director of Clinical Research | NovaGo Therapeutics AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Querschnittgelähmte, Klinikum Bayreuth | Recruiting | Bayreuth | Germany | |||
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| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
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| Baseline up to 6 months |
| Effect on daily life functioning according to change in Version III of the Spinal Cord Independence Measure (SCIM-III) | The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities. | Baseline to 6 months |
| Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost |
| Not yet recruiting |
| Halle |
| Germany |
| Klinik für Paraplegiologie, Universitätsklinikum Heidelberg | Recruiting | Heidelberg | Germany |
| Zentrum für Rückenmarksverletzte, Unfallklinik Murnau | Recruiting | Murnau am Staffelsee | Germany |
| Swiss Paraplegic Centre | Recruiting | Nottwil | Switzerland |
| Universitätsklinik Balgrist | Recruiting | Zurich | Switzerland |