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This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUM-201 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUM-201 | Drug | 1.6 mg/kg/day, administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the long-term safety and tolerability of LUM-201 |
| Day 1 - Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the long-term effect of LUM-201 on growth. |
| Day 1 - Month 36 |
| To evaluate the long-term effect of LUM-201 on pharmacodynamic (PD) markers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lumos Pharma | Contact | 515-598-2921 | clinical.trials@lumos-pharma.com |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Day 1 - Month 36 |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |