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出境医 / 临床实验 / Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis (ALS and PLS)
Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis (ALS and PLS)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amyotrophic Lateral Sclerosis Motor Neuron Disease | Drug: carbidopa-levodopa Drug: Placebo Oral Tablet | Phase 1 |
Study Design
| 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 2022 |
| Estimated Study Completion Date : | May 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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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.
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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
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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.
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Drug: Placebo Oral Tablet
Placebo will be given to maintain blinding of participants and study team.
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Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
- 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
- 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.
- 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.
- Upper extremity function [ Time Frame: At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm) ]9-hole peg test
- 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.
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Locations
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Timothy M Miller, MD, PhD | Washington University School of Medicine |
| Tracking Information | |||||||
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| First Submitted Date ICMJE | April 10, 2019 | ||||||
| First Posted Date ICMJE | April 26, 2019 | ||||||
| Last Update Posted Date | June 7, 2021 | ||||||
| Actual Study Start Date ICMJE | May 13, 2019 | ||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis | ||||||
| Official Title ICMJE | Sinemet in ALS and PLS | ||||||
| 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 Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||
| Estimated Enrollment ICMJE |
15 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | May 2022 | ||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03929068 | ||||||
| Other Study ID Numbers ICMJE | Sinemet-001 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Washington University School of Medicine | ||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Washington University School of Medicine | ||||||
| Verification Date | June 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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