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| Name | Class |
|---|---|
| Western ALS Study Group | UNKNOWN |
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ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS.
Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics and it is approved for use for patients with another disorder, the effectiveness of rasagiline for patients with ALS has not been tested.
The specific aim of this screen study is to determine whether rasagiline is safe in this patient population and if the drug has the potential to slow ALS disease progression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rasagiline | Experimental | Treated for 12 months with rasagiline 2mg orally, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rasagiline | Drug | rasagiline 2 mg daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) | The primary outcome measure is the difference in the rate of decline in function, as detected by the ALS Functional Rating Scale - Revised (ALSFRS-R) in patients taking rasagiline compared to a database of patients from randomized clinical trials conducted during 1997-2007. Minimum score is 0 (no function) to Maximum score is 48 (normal function) | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Time to Treatment Failure | This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation >= 23 hours/day for 14 days or more. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in JC-1 Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarkerJC-1 red/green fluorescence ratio. We measured at baseline, 6 months and 12 months. | Baseline, 6 months, 12 months |
| Change in Mitotracker Mitochondrial Biomarkers |
Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yunxia Wang, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Neurological Institute | Phoenix | Arizona | 85018 | United States | ||
| California Pacific Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rasagiline | Open label study of rasagiline at 2 mg daily for 12 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The 12 month change in mitochondrial biomarkerMitotracker. We measured at baseline, 6 months and 12 months.
| Baseline, 6 months, 12 months |
| Change in Percent Annexin V Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker Annexin V %. We measured at baseline, 6 months and 12 months. | Baseline, 6 months, 12 months |
| Change in BCL2/BAX Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker BCL2/BAX. We measured at baseline, 6 months and 12 months. | Baseline, 6 months, 12 months |
| Change in ORAC Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months. | Baseline, 6 months, 12 months |
| San Francisco |
| California |
| 94118 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University Of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Tennessee | Memphis | Tennessee | 38104 | United States |
| The Methodist Hospital System | Houston | Texas | 77030 | United States |
| McGill University | Montreal | Quebec | H3A 2B4 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rasagiline | Open label study of 2 mg rasagiline daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) | The primary outcome measure is the difference in the rate of decline in function, as detected by the ALS Functional Rating Scale - Revised (ALSFRS-R) in patients taking rasagiline compared to a database of patients from randomized clinical trials conducted during 1997-2007. Minimum score is 0 (no function) to Maximum score is 48 (normal function) | The placebo arm are from the randomized, controlled studies in ALS performed during 2004-2010, corrected for symptom duration. | Posted | Mean | Standard Error | units on a scale | up to 12 months |
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| Secondary | Difference in Time to Treatment Failure | This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation >= 23 hours/day for 14 days or more. | Failure was defined as death, endotracheal intubation, tracheostomy-assisted ventilation, or use of noninvasive ventilation 23 hours/day for 14 days or more. It is defined in years. | Posted | Median | 95% Confidence Interval | years | up to 12 months |
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| Other Pre-specified | Change in JC-1 Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarkerJC-1 red/green fluorescence ratio. We measured at baseline, 6 months and 12 months. | Only 14 subjects that completed the study were able to have this biomarker analyzed. | Posted | Mean | 95% Confidence Interval | ratio | Baseline, 6 months, 12 months |
|
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| Other Pre-specified | Change in Mitotracker Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarkerMitotracker. We measured at baseline, 6 months and 12 months. | Only 17 subjects that completed the study were able to have this biomarker analyzed. | Posted | Mean | 95% Confidence Interval | Relative Fluorescent Intensity | Baseline, 6 months, 12 months |
|
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| Other Pre-specified | Change in Percent Annexin V Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker Annexin V %. We measured at baseline, 6 months and 12 months. | Only 17 subjects that completed the study were able to have this biomarker analyzed. | Posted | Mean | 95% Confidence Interval | Annexin V % | Baseline, 6 months, 12 months |
|
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| Other Pre-specified | Change in BCL2/BAX Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker BCL2/BAX. We measured at baseline, 6 months and 12 months. | Only 10 subjects that completed the study were able to have this biomarker analyzed. | Posted | Mean | 95% Confidence Interval | Ratio | Baseline, 6 months, 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in ORAC Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months. | Only 17 subjects that completed the study were able to have this biomarker analyzed. | Posted | Mean | 95% Confidence Interval | Trolox equivalents | Baseline, 6 months, 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in ORAC Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months. | Only 17 subjects that completed the study were able to have this biomarker analyzed. | Posted | Mean | 95% Confidence Interval | umol Trolox equivalents | Baseline, 6 months, 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in ORAC Mitochondrial Biomarkers | The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months. | Only 17 subjects that completed the study were able to have this biomarker analyzed. | Posted | Mean | 95% Confidence Interval | Trolox equivalents | Baseline, 6 months, 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rasagiline | Treated for 12 months with rasagiline 2mg orally, once daily. rasagiline: rasagiline 2 mg daily for 12 months | 1 | 36 | 17 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Fractured pelvic bone |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Dizziness | Blood and lymphatic system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Hypertension | Blood and lymphatic system disorders |
| |||
| nausea | Gastrointestinal disorders |
| |||
| Xerostomia | General disorders |
| |||
| Lab abnormality (elevated ALT) | Hepatobiliary disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yunxia Wang | UKansasMCRI | 913-588-6970 | ywang@kumc.edu |
| 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 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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