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Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa (Sinemet) to attempt to improve spasticity in ALS and PLS patients. However, data on the efficacy of carbidopa/levodopa is limited. Given the limited data and potential to improve the quality of life of these patients, the effectiveness of carbidopa-levodopa in ALS and PLS patients with severe spasticity should be studied. The investigators hypothesis is that administration of carbidopa-levodopa will improve spasticity in ALS and PLS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbidopa-levodopa | Active Comparator | Each tablet of carbidopa-levodopa in this study will be equivalent to half of a standard carbidopa-levodopa 25/100mg tablet. Participants will take one tablet three times a day for the first week of the study period, increasing to two tablets three times a day for the remainder of the study period. |
|
| Placebo | Placebo Comparator | Participants will take one placebo tablet three times a day for the first week of the study period, increasing to two tablets three times a day for the remainder of the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbidopa-levodopa | Drug | Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa to attempt to improve spasticity in ALS and PLS patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale - Change of spasticity severity from baseline with treatment and placebo | Numerical rating scale from 0-10, where 0 is no spasticity and 10 is worst possible spasticity | Weekly from screening to end of study (six weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale - Change of pain severity from baseline with treatment and placebo | Numerical rating scale from 0-10, where 0 is no pain and 10 is worst possible pain | Weekly from screening to end of study (six weeks) |
| Visual Analog Scale - Change of muscle spasm severity from baseline with treatment and placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy M Miller, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 15, 2024 | |
| Reset | Nov 1, 2024 | |
| Release | Nov 19, 2024 | |
| Unrelease | Nov 19, 2024 | |
| Release | Nov 25, 2024 | |
| Reset | Jan 10, 2025 | |
| Release | Aug 18, 2025 | |
| Reset | Sep 8, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2019 | Apr 22, 2019 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 15, 2024 | Nov 1, 2024 | |||
| Nov 19, 2024 | Nov 19, 2024 |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D016472 | Motor Neuron Disease |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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Identified participants will be randomized to receive either placebo or carbidopa-levodopa for a period of three weeks before crossing over to the other arm of the study. The two periods will be separated by a one day washout period.
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|
| Placebo Oral Tablet | Drug | Placebo will be given to maintain blinding of participants and study team. |
|
Numerical rating scale from 0-10, where 0 is no muscle spasm and 10 is worst possible muscle spasm |
| Weekly from screening to end of study (six weeks) |
| Strength | Medical Research Council scale for muscle strength which grades power on a scale of 0 to 5 in relation to the maximum expected for that muscle, 0 being no movement observed to 5 being muscle contracts normally against full resistance. | At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) |
| Spasticity | The Ashworth scale measures severity of spasticity on a scale of 1 to 5, where 1 is normal muscle tone and 5 is a rigid limb. | At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) |
| Upper extremity function | 9-hole peg test | At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) |
| Lower extremity function:10-meter Walk Test | 10-meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. | At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) |
| Lower extremity function: Timed Up and Go (TUG) Test | The TUG test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down to asses a person's mobility and lower extremity function. | At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) |
| Nov 25, 2024 | Jan 10, 2025 |
| Aug 18, 2025 | Sep 8, 2025 |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |