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

NCT ID: NCT03929068

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2022-07-08

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.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

carbidopa-levodopa

Each tablet of carbidopa-levodopa in this study will be equivalent to half of a standard carbidopa-levodopa 25/100mg tablet. Participants will take one tablet three times a day for the first week of the study period, increasing to two tablets three times a day for the remainder of the study period.

Group Type: ACTIVE_COMPARATOR

carbidopa-levodopa

Intervention Type: DRUG

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.

Placebo

Participants will take one placebo tablet three times a day for the first week of the study period, increasing to two tablets three times a day for the remainder of the study period.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo will be given to maintain blinding of participants and study team.

Interventions

carbidopa-levodopa

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.

Intervention Type: DRUG

Placebo Oral Tablet

Placebo will be given to maintain blinding of participants and study team.

Intervention Type: DRUG

Other Intervention Names

Sinemet

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy M Miller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Sinemet-001

Identifier Type: -

Identifier Source: org_study_id