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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The use of Thalidomide in patients with ALS who have disease progression.
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug | Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS | Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS | survival and progression free suvival will be assessed from the date of initial therapy on study to date od death. Survival and progresion free survival wil be analyzed using the Kaplan Meier method |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elijah Stommel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hichcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |