Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Conditions
Keywords
ALS, PLS, Primary Lateral Sclerosis
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.
Interventions
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.
DRUGPlacebo Oral Tablet
Placebo will be given to maintain blinding of participants and study team.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| Upper extremity function | At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) | 9-hole peg test |
Countries
United States
Outcome results
None listed