Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis
- Conditions
- Motor Neuron DiseaseAmyotrophic Lateral Sclerosis
- Interventions
- Drug: carbidopa-levodopaDrug: Placebo Oral Tablet
- Registration Number
- NCT03929068
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Diagnosis of ALS or PLS
- Age greater than 18 years
- Clinically significant spasticity.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description carbidopa-levodopa carbidopa-levodopa 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 Oral Tablet 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.
- Primary Outcome Measures
Name Time Method Visual Analog Scale - Change of spasticity severity from baseline with treatment and placebo Weekly from screening to end of study (six weeks) Numerical rating scale from 0-10, where 0 is no spasticity and 10 is worst possible spasticity
- Secondary Outcome Measures
Name Time Method Visual Analog Scale - Change of pain severity from baseline with treatment and placebo Weekly from screening to end of study (six weeks) Numerical rating scale from 0-10, where 0 is no pain and 10 is worst possible pain
Visual Analog Scale - Change of muscle spasm severity from baseline with treatment and placebo Weekly from screening to end of study (six weeks) Numerical rating scale from 0-10, where 0 is no muscle spasm and 10 is worst possible muscle spasm
Strength At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) 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.
Spasticity At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) 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.
Upper extremity function At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) 9-hole peg test
Lower extremity function:10-meter Walk Test At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) 10-meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
Lower extremity function: Timed Up and Go (TUG) Test At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) 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.
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States