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

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ClinicalTrials.gov Identifier: NCT03929068
Recruitment Status : Enrolling by invitation
First Posted : April 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Motor Neuron Disease Drug: carbidopa-levodopa Drug: Placebo Oral Tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sinemet in ALS and PLS
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: Sinemet

Placebo Comparator: 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.
Drug: Placebo Oral Tablet
Placebo will be given to maintain blinding of participants and study team.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929068


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Timothy M Miller, MD, PhD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03929068     History of Changes
Other Study ID Numbers: Sinemet-001
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Washington University School of Medicine:
ALS
PLS
Primary Lateral Sclerosis

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists