Clinical trial NCT03929068: Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis
Official title: Sinemet in ALS and PLS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Keywords: ALS
PLS
Primary Lateral Sclerosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Identified participants will be randomized to receive either placebo or carbidopa-levodopa for a period of three weeks before crossing over to the other arm of the study. The two periods will be separated by a one day washout period.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual Analog Scale - Change of spasticity severity from baseline with treatment and placebo
timeFrame: Weekly from screening to end of study (six weeks)
Secondary outcomes:
measure: Visual Analog Scale - Change of pain severity from baseline with treatment and placebo
timeFrame: Weekly from screening to end of study (six weeks)
measure: Visual Analog Scale - Change of muscle spasm severity from baseline with treatment and placebo
timeFrame: Weekly from screening to end of study (six weeks)
measure: Strength
timeFrame: At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
measure: Spasticity
timeFrame: At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
measure: Upper extremity function
timeFrame: At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
measure: Lower extremity function:10-meter Walk Test
timeFrame: At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
measure: Lower extremity function: Timed Up and Go (TUG) Test
timeFrame: At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Timothy M Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: