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

Phase 1
Completed
Conditions
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Interventions
Drug: carbidopa-levodopa
Drug: Placebo Oral Tablet
Registration Number
NCT03929068
Lead Sponsor
Washington University School of Medicine
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Diagnosis of ALS or PLS
  • Age greater than 18 years
  • Clinically significant spasticity.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
carbidopa-levodopacarbidopa-levodopaEach 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.
PlaceboPlacebo Oral TabletParticipants 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.
Primary Outcome Measures
NameTimeMethod
Visual Analog Scale - Change of spasticity severity from baseline with treatment and placeboWeekly from screening to end of study (six weeks)

Numerical rating scale from 0-10, where 0 is no spasticity and 10 is worst possible spasticity

Secondary Outcome Measures
NameTimeMethod
Visual Analog Scale - Change of pain severity from baseline with treatment and placeboWeekly from screening to end of study (six weeks)

Numerical rating scale from 0-10, where 0 is no pain and 10 is worst possible pain

Visual Analog Scale - Change of muscle spasm severity from baseline with treatment and placeboWeekly from screening to end of study (six weeks)

Numerical rating scale from 0-10, where 0 is no muscle spasm and 10 is worst possible muscle spasm

StrengthAt screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)

Medical Research Council scale for muscle strength which grades power on a scale of 0 to 5 in relation to the maximum expected for that muscle, 0 being no movement observed to 5 being muscle contracts normally against full resistance.

SpasticityAt screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)

The Ashworth scale measures severity of spasticity on a scale of 1 to 5, where 1 is normal muscle tone and 5 is a rigid limb.

Upper extremity functionAt screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)

9-hole peg test

Lower extremity function:10-meter Walk TestAt screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)

10-meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.

Lower extremity function: Timed Up and Go (TUG) TestAt screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)

The TUG test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down to asses a person's mobility and lower extremity function.

Trial Locations

Locations (1)

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

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