Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis (ALS and PLS)

The Washington University

Status and phase: Completed; Phase 1

Conditions: Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Treatments: Drug: Placebo Oral Tablet; Drug: carbidopa-levodopa

Study type: Interventional

Funder types: Other

Identifiers

NCT03929068

Sinemet-001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

15 participants in 2 patient groups, including a placebo group

carbidopa-levodopa

Active Comparator group

Description:

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.

Treatment:

Drug: carbidopa-levodopa

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Oral Tablet