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

Washington University School of Medicine15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis Motor Neuron Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Weekly from screening to end of study (six weeks)

Secondary Outcomes

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

Time frame: Weekly from screening to end of study (six weeks)

Visual Analog Scale - Change of muscle spasm severity from baseline with treatment and placebo

Numerical rating scale from 0-10, where 0 is no muscle spasm and 10 is worst possible muscle spasm

Time frame: 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.