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Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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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.

Inclusion Criteria:
- Diagnosis of ALS or PLS
- Age greater than 18 years
- Clinically significant spasticity.
Exclusion Criteria:
- Individuals currently taking carbidopa-levodopa or with known hypersensitivity of any
component of carbidopa-levodopa
- Narrow-angle glaucoma
- Current use of a non-selective monoamine oxidase inhibitor (MAOI)
- History of malignant melanoma or suspicious skin lesions
- History of depression, suicidal ideation, or psychosis
- History of myocardial infarction, ventricular arrhythmia, or severe cardiopulmonary
disease
- Uncontrolled hypertension
- Asthma
- Renal disease
- Hepatic disease
- Endocrine disease
- History of peptic ulcer
- Pregnant and/or breastfeeding
- Current participation in another interventional study

Locations
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