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Completed

NCT Number: NCT03929068

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbidopa-levodopa

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.

Other names: Sinemet

Placebo oral tablet

Drug

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

Primary outcomes

  1. Visual Analog Scale - Change of spasticity severity from baseline with treatment and placebo

    Time frame: Weekly 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 outcomes

  1. Visual Analog Scale - Change of pain severity from baseline with treatment and placebo

    Time frame: Weekly 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

  2. Visual Analog Scale - Change of muscle spasm severity from baseline with treatment and placebo

    Time frame: Weekly 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

  3. Strength

    Time frame: At 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.

  4. Spasticity

    Time frame: At 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.

  5. Upper extremity function

    Time frame: At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)

    9-hole peg test

  6. Lower extremity function:10-meter Walk Test

    Time frame: At 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.

  7. Lower extremity function: Timed Up and Go (TUG) Test

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Sinemet in ALS and PLS

Acronym: ALS and PLS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2019
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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