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

Amyotrophic Lateral Sclerosis Clinical Trial

— ALS and PLS  

Official title:

Sinemet in ALS and PLS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929068
• Other study ID #: Sinemet-001
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2019
• Est. completion date: July 8, 2022

Study information

• Verified date: July 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 8, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weekly from screening to end of study (six weeks)
Secondary	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	Weekly from screening to end of study (six weeks)
Secondary	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	Weekly from screening to end of study (six weeks)
Secondary	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.	At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
Secondary	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.	At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
Secondary	Upper extremity function	9-hole peg test	At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
Secondary	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.	At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)
Secondary	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.	At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)