Sinemet in ALS and PLS

Study Purpose:

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 Status:

Not recruiting


Amyotrophic Lateral Sclerosis , Motor Neuron Disease

Study Type:


Type of Intervention:


Intervention Name:

carbidopa-levodopa, Placebo Oral Tablet




Phase 1

Study Chair(s)/Principal Investigator(s):

Timothy M Miller, MD, PhD, Washington University School of Medicine ID:


Neals Affiliated?


Coordinating Center Contact Information

Study Sponsor:

Washington University School of Medicine

Estimated Enrollment:


Estimated Study Start Date:

05 / 13 / 2019

Estimated Study Completion Date:

07 / 08 / 2022

Posting Last Modified Date:

07 / 11 / 2022

Date Study Added to

04 / 26 / 2019

Minimum Age:

18 Years

Maximum Age:


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

Washington University School of Medicine

Saint Louis, Missouri 63110
United States