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

Primary Purpose

Amyotrophic Lateral Sclerosis, Motor Neuron Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

carbidopa-levodopa

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, PLS, Primary Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

carbidopa-levodopa

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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 placebo

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

Strength

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.

Spasticity

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 function

9-hole peg test

Lower extremity function:10-meter Walk Test

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) Test

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.

Full Information

NCT ID

NCT03929068

First Posted

April 10, 2019

Last Updated

July 8, 2022

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03929068

Brief Title

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

Acronym

ALS and PLS

Official Title

Sinemet in ALS and PLS

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

May 13, 2019 (Actual)

Primary Completion Date

July 8, 2022 (Actual)

Study Completion Date

July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis, Motor Neuron Disease

Keywords

ALS, PLS, Primary Lateral Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

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

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

carbidopa-levodopa

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

carbidopa-levodopa

Other Intervention Name(s)

Sinemet

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Weekly from screening to end of study (six weeks)

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Weekly from screening to end of study (six weeks)

Title

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

Description

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

Time Frame

Weekly from screening to end of study (six weeks)

Title

Strength

Description

Time Frame