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
Disease:
Amyotrophic Lateral Sclerosis , Motor Neuron Disease
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
carbidopa-levodopa, Placebo Oral Tablet
Placebo:
Yes
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
Timothy M Miller, MD, PhD, Washington University School of Medicine
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Washington University School of Medicine
Estimated Enrollment:
15
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 neals.org:
04 / 26 / 2019
Minimum Age:
18 Years
Maximum Age:
N/A
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