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

• Status: Enrolling by invitation
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

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