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Enhancement of Stroke Rehabilitation With Levodopa (ESTREL)

Primary Purpose

Acute Stroke, Stroke Rehabilitation

Status
Recruiting
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
IMP Levodopa 100mg/Carbidopa 25mg
Matching placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Levodopa/ Carbidopa, Fugl-Meyer-Motor-Assessment (FMMA), acute ischemic stroke, acute hemorrhagic stroke, Rehabilitation, Recovery

Eligibility Criteria

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

Inclusion Criteria:

  • Acute ischemic or hemorrhagic (i.e. intracerebral hemorrhage excluding subarachnoid hemorrhage and cerebal venous sinus thrombosis) stroke ≤ 7 days prior to randomization
  • Clinically meaningful hemiparesis (i.e. scoring a total of ≥ 3 points on the following NIH stroke scale score items (i) motor arm, (ii) motor leg, (iii) limb ataxia; a distal arm paresis is equivalent to one of the aforementioned (i-iii))
  • Time of randomization ≥24-hours since thrombolysis or thrombectomy
  • In-hospital rehabilitation required
  • Capable to participate in standardized rehabilitation therapy
  • Informed consent of patient or next of kin

Exclusion Criteria:

  • Diagnosis of Parkinson's Disease
  • Use of Levodopa mandatory according to judgement of treating physician
  • Inability or unwillingness to comply with study procedures including adherence to study drug intake (orally, or via nasogastric tube or percutaneous endoscopic gastrostomy tube)
  • Severe aphasia (i.e. unable to follow two-stage-commands)
  • Previously dependent in the basal activities of daily living (defined as modified Ranking Scale prior to stroke > 3)
  • Pre-existing hemiparesis
  • Known hypersensitivity to Levodopa/Carbidopa and other contraindications for Levodopa/Carbidopa as outlined in the summary of product characteristics
  • Women who are pregnant or breast feeding, or who intend to become pregnant during the course of the study. Women of childbearing age must take a pregnancy test to be eligible for the study.
  • Lack of safe contraception, defined as: Female Participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases. Female Participants who are surgically sterilized / hysterectomized or post- menopausal for longer than 2 years are not considered as being of child- bearing potential.

Sites / Locations

  • Kantonsspital Aarau, NeurozentrumRecruiting
  • RehaClinic AG
  • Kantonsspital BadenRecruiting
  • Felix Platter Spital
  • Stroke-Center Universitätsspital BaselRecruiting
  • Inselspital, Universitätsklinik für NeurologieRecruiting
  • Kantonsspital Graubünden, Departement Innere Medizin / NeurologieRecruiting
  • HFR Fribourg Hopital Cantonal, U. de NeurologieRecruiting
  • Centre hospitalier universitaire vaudois, Service de NeurologieRecruiting
  • HFR Meyriez-Murten, Clinique de Réhabilitation
  • Kantonsspital MünsterlingenRecruiting
  • Reha Rheinfelden
  • Hôpital du Valais - Sion, Service de neurologie
  • Hôpital du Valais - Sion
  • Kantonsspital St.Gallen, Klinik für NeurologieRecruiting
  • Rehazentrum Valens, Klinik für Neurologie und Neurorehabilitation
  • Cereneo Schweiz AG
  • Zürcher RehaZentrum Wald
  • Rheinburg Klinik AG
  • Kantonsspital WinterthurRecruiting
  • Rehaklinik Zihlschlacht
  • Klinik Lengg AG
  • Head Stroke Center Klinik HirslandenRecruiting
  • Universitätsspital Zürich, Klinik für NeurologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental Intervention

Control Intervention

Arm Description

White Investigational Medicinal Product (IMP)- capsules of a combination of IMP Levodopa 100mg/Carbidopa 25mg.

Matching placebo, identical in aspect, texture, and taste when compared to the IMP. Procedures regarding route of administration, study treatment duration and treatment phases will be identical in the IMP- and the placebo-group.

Outcomes

Primary Outcome Measures

Between-group difference of scores in the Fugl-Meyer-Motor Assessment (FMMA)
FMMA is a stroke-specific impairment index designed to assess motor recovery. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale (0=cannot perform; 1=performs partially and 2= performs fully). FMMA total scores range from 0 (no movements) to 100 (normal movements) with 66 points for movements of the upper limbs (FMMA-UE) and 34 for those of the lower limbs (FMMA-LE). A difference of 5.25 points for the upper extremity and 6 points for the lower extremity part of the score are described as minimal clinically important difference. For this study, based on these data, 6 points difference are considered a patient-relevant difference between both treatment groups for the primary endpoint.

Secondary Outcome Measures

Change in NIH-Stroke Scale score (NIHSS)
To objectively quantify the impairment caused by a stroke. NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Change in modified Rankin Scale Score (mRS)
Scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.
Change in Stroke rehabilitation outcomes for disease specific morbidity and quality of life - PROMIS 29
Patient-self-assessment in the following categories: 1) physical function, 2) anxiety, 3) depression, 4) fatigue, 5) sleep disturbance, 6) ability to participate in social roles and activities, 7) pain interference and 8) pain intensity. Each of the domains 1 to 7 are assessed with 4 questions. Items are scored on 1 of 5 levels based on the ability of the participant to perform activities or the self-assessment of the participant in the various domains. Pain intensity is scored on a visual analogue scale of 0 to 10.
Change in Stroke rehabilitation outcomes for disease specific morbidity and quality of life - PROMIS 10
Patient-self-assessment Patient-Reported Outcomes Measurement Information System (PROMIS) 10 addresses general health aspects, quality of life, pain, mood, anxiety, fatigue and social participation; PROMIS-10 covers the outcome domains considered most important
Change in Patient-reported assessment of relevance of motor improvement
Patients Questionnaire asking whether there is improvement in motor function since the last study visit and if so, whether this improvement is relevant in patients personal perception (yes/ no)
Change in Rivermead Mobility Index (RMI)
15 items that measure the ability of patients to make postural adjustments (e.g, move in bed), transfer (e.g. between bed to chair), walk, and use stairs and is scored from 0-15 Points. A RMI score of ≥ 7 translates into the ability of the patient walking independently of the assistance of another Person.
mortality (of any cause)
death rate
recurrent stroke (any type)
recurrent stroke (any type)
Rate of pre- specified Adverse Events of Interest
Nausea, Vomiting, Taste disturbances, Dry mouth, Anorexia, Arrhythmias, Postural hypotension Syncope (unconsciousness for a short time as a result of reduced blood flow to the brain), drowsiness (including sudden onset of sleep) Fatigue, Dementia, Psychoses (a distorted perception of reality), Hallucinations, Confusion, Euphoria, Abnormal dreams, Insomnia, Depression, Anxiety, Dizziness, Dystonia (involuntary contractions), Dyskinesia (inability to control voluntary movements), Chorea (sudden twitching of the face and shoulders)
number of re-hospitalizations
re-hospitalization
Change in Motricity Index (MI)
Two subscales, one for the upper extremity (UE) (total score range 0 to 100) and one for the lower extremity (LE) (total score range 0 to 100). It measures isometric muscle strength (0 = no movement; 100 = normal)
Change in Trunk Control Test (TCT)
Assesses the trunk abilities of the patient , contains 4 items, with item scores ranging from 0 to 25. The sitting balance item assesses the patients' ability to sit during 30 seconds without trunk and feet support and has a predictive value for recovery of walking poststroke
Change in Action Research Arm Test (ARAT)
Assesses the patients' ability to grasp (subscale with 6 items), grip (subscale with 4 items), pinch (subscale with 6 items) and perform gross movements (subscale with 3 items) with the upper extremity. Score: 0 = no movement / 1= movement task is partially performed / 2 = movement task is completed but takes abnormally long / 3 = movement is performed normally
Change in Box- and Block Test (BBT)
Patients (seated in front of a square box with two compartments) are asked to move as many wooden cubes as possible from one compartment to the other within 60 seconds of testing time.
Change in Functional Ambulation Categories (FAC)
Classification (score range 0 to 5) regarding the ability to walk independently, with or without a walking aid and takes the type of walking surface into account. Rating: 0 = Patient cannot walk, or needs help from 2 or more persons = Patient needs firm continuous support from 1 person who helps carrying weight and with balance = Patient needs continuous or intermittent support of one person to help with balance and coordination = Patient requires verbal supervision or stand-by help from one person without physical contact = Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces = Patient can walk independently anywhere
Change in Ten-Meter Walk Test (10MWT)
Walking speed and cadence over a 10 meter track at both a comfortable and a maximum Speed; time in seconds over 10-meter walking distance
Change in Jamar dynamometer testing (JDT)
grip strength and strength of the forearm (in kilogram)
Change in Montreal Cognitive Assessment (MoCA)
Assesses cognitive domains: Short-term memory recall task (5 points).Visuospatial abilities assessed using clock-drawing task (3 points) and 3-dimensional cube copy (1 point). Executive functions assessed using alternation task. Attention, concentration, working memory evaluated using a sustained attention task (target detection using tapping; 1 point), serial subtraction task (3 points), digits forward and backward (1 point each). Languages assessed using 3-item confrontation naming task with low-familiarity animals (lion, camel, rhinoceros; 3 points), repetition of 2 complex sentences (2 points), and fluency task. Orientation to time and place evaluated by asking for date and city in which the test is occurring (6 points). A score of 26 or over is considered to be normal (range 0 to 30)
Change in Daily activity measurement with movement sensor
Movement sensors allow assessment of physical activity engagement and upper limb use in daily life situations without physically hampering the patient in the performance of their daily activities
Rate of Serious Adverse Event (SAE)
Any untoward medical occurrence that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Between-group difference of scores in the Fugl-Meyer-Motor Assessment (FMMA)
FMMA is a stroke-specific impairment index designed to assess motor recovery. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale (0=cannot perform; 1=performs partially and 2= performs fully). FMMA total scores range from 0 (no movements) to 100 (normal movements) with 66 points for movements of the upper limbs (FMMA-UE) and 34 for those of the lower limbs (FMMA-LE). A difference of 5.25 points for the upper extremity and 6 points for the lower extremity part of the score are described as minimal clinically important difference. For this study, based on these data, 6 points difference are considered a patient-relevant difference between both treatment groups for the primary endpoint.

Full Information

First Posted
November 7, 2018
Last Updated
September 1, 2023
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03735901
Brief Title
Enhancement of Stroke Rehabilitation With Levodopa
Acronym
ESTREL
Official Title
Enhancement of Stroke Rehabilitation With Levodopa (ESTREL): a Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Trial investigates the benefits and harms of Levodopa /Carbidopa 100/25mg compared to placebo (given in addition to standardized rehabilitation based on the principles of motor learning) and whether there is an association with a patient-relevant enhancement of functional recovery in acute stroke patients. Study participants will be randomized 1:1.
Detailed Description
Trial investigates whether Levodopa/Carbidopa compared to placebo given in addition to standardized rehabilitative therapy in patients with acute stroke is associated with a) patient relevant improvements of physical function b) improvement in patient-self assessed general health aspects, pain, mood, anxiety, fatigue and social participation c) long-term sustainability of a patient-relevant improvement of motor function d) improvement of selective hand and wrist movement e) a higher rate of patients walking independently of the help of another person. f) less severe impairment g) a higher level of activity of daily living h) improvements of quality of life (i) better cognitive performance (j) no signals of harms (i.e. indications for increased all-cause mortality, recurrent stroke or serious adverse events). Estrel-Longterm: optional prolongation of the observational study phase. To investigate the long-term outcomes of our study population the investigator aim to offer an optional prolongation of the observational phase to the participants through regular structured (once yearly) telephone visits. The telephone visits will be carried out annually for the following 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke, Stroke Rehabilitation
Keywords
Levodopa/ Carbidopa, Fugl-Meyer-Motor-Assessment (FMMA), acute ischemic stroke, acute hemorrhagic stroke, Rehabilitation, Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomized 1:1
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
610 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Intervention
Arm Type
Active Comparator
Arm Description
White Investigational Medicinal Product (IMP)- capsules of a combination of IMP Levodopa 100mg/Carbidopa 25mg.
Arm Title
Control Intervention
Arm Type
Placebo Comparator
Arm Description
Matching placebo, identical in aspect, texture, and taste when compared to the IMP. Procedures regarding route of administration, study treatment duration and treatment phases will be identical in the IMP- and the placebo-group.
Intervention Type
Drug
Intervention Name(s)
IMP Levodopa 100mg/Carbidopa 25mg
Intervention Description
Study treatment will comprise 3 phases: Dose escalation phase: On day 1-3, patients will receive IMP solely in the morning; on day 4-6 in the morning and at lunch time; full study treatment phase: from day 7 to day 34, 3 times per day (tid). Treatment will stop with a tapering phase: On day 35-37, patients will receive IMP in the morning and at lunch time; on day 38 and 39 solely in the morning.
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
Study treatment will comprise 3 phases: Dose escalation phase: On day 1-3, patients will receive Placebo solely in the morning; on day 4-6 in the morning and at lunch time; full study treatment phase: from day 7 to day 34, Placebo capsules 3 times per day (tid). Treatment will stop with a tapering phase: On day 35-37, patients will receive Placebo in the morning and at lunch time; on day 38 and 39 solely in the morning.
Primary Outcome Measure Information:
Title
Between-group difference of scores in the Fugl-Meyer-Motor Assessment (FMMA)
Description
FMMA is a stroke-specific impairment index designed to assess motor recovery. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale (0=cannot perform; 1=performs partially and 2= performs fully). FMMA total scores range from 0 (no movements) to 100 (normal movements) with 66 points for movements of the upper limbs (FMMA-UE) and 34 for those of the lower limbs (FMMA-LE). A difference of 5.25 points for the upper extremity and 6 points for the lower extremity part of the score are described as minimal clinically important difference. For this study, based on these data, 6 points difference are considered a patient-relevant difference between both treatment groups for the primary endpoint.
Time Frame
Assessed 3 months +/- 14 days after randomization
Secondary Outcome Measure Information:
Title
Change in NIH-Stroke Scale score (NIHSS)
Description
To objectively quantify the impairment caused by a stroke. NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in modified Rankin Scale Score (mRS)
Description
Scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12/24/36/48/60 months +/- 30 days after randomization
Title
Change in Stroke rehabilitation outcomes for disease specific morbidity and quality of life - PROMIS 29
Description
Patient-self-assessment in the following categories: 1) physical function, 2) anxiety, 3) depression, 4) fatigue, 5) sleep disturbance, 6) ability to participate in social roles and activities, 7) pain interference and 8) pain intensity. Each of the domains 1 to 7 are assessed with 4 questions. Items are scored on 1 of 5 levels based on the ability of the participant to perform activities or the self-assessment of the participant in the various domains. Pain intensity is scored on a visual analogue scale of 0 to 10.
Time Frame
Assessed 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Stroke rehabilitation outcomes for disease specific morbidity and quality of life - PROMIS 10
Description
Patient-self-assessment Patient-Reported Outcomes Measurement Information System (PROMIS) 10 addresses general health aspects, quality of life, pain, mood, anxiety, fatigue and social participation; PROMIS-10 covers the outcome domains considered most important
Time Frame
Assessed 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12/24/36/48/60 months +/- 30 days after randomization
Title
Change in Patient-reported assessment of relevance of motor improvement
Description
Patients Questionnaire asking whether there is improvement in motor function since the last study visit and if so, whether this improvement is relevant in patients personal perception (yes/ no)
Time Frame
Assessed 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Rivermead Mobility Index (RMI)
Description
15 items that measure the ability of patients to make postural adjustments (e.g, move in bed), transfer (e.g. between bed to chair), walk, and use stairs and is scored from 0-15 Points. A RMI score of ≥ 7 translates into the ability of the patient walking independently of the assistance of another Person.
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12/24/36/48/60 months +/- 30 days after randomization
Title
mortality (of any cause)
Description
death rate
Time Frame
Throughout the whole study period from Day 1 to Visit 12/24/36/48/60 months +/- 30 days after randomization
Title
recurrent stroke (any type)
Description
recurrent stroke (any type)
Time Frame
Throughout the whole study period from Day 1 to Visit 12/24/36/48/60 months +/- 30 days after randomization
Title
Rate of pre- specified Adverse Events of Interest
Description
Nausea, Vomiting, Taste disturbances, Dry mouth, Anorexia, Arrhythmias, Postural hypotension Syncope (unconsciousness for a short time as a result of reduced blood flow to the brain), drowsiness (including sudden onset of sleep) Fatigue, Dementia, Psychoses (a distorted perception of reality), Hallucinations, Confusion, Euphoria, Abnormal dreams, Insomnia, Depression, Anxiety, Dizziness, Dystonia (involuntary contractions), Dyskinesia (inability to control voluntary movements), Chorea (sudden twitching of the face and shoulders)
Time Frame
Throughout the study period from Day 1 to Visit 3 ( 3 months +/- 14 days after randomization)
Title
number of re-hospitalizations
Description
re-hospitalization
Time Frame
Throughout the whole study period (Visit 1 = Baseline (day 0) to Visit 12 months +/- 30 days after randomization
Title
Change in Motricity Index (MI)
Description
Two subscales, one for the upper extremity (UE) (total score range 0 to 100) and one for the lower extremity (LE) (total score range 0 to 100). It measures isometric muscle strength (0 = no movement; 100 = normal)
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Trunk Control Test (TCT)
Description
Assesses the trunk abilities of the patient , contains 4 items, with item scores ranging from 0 to 25. The sitting balance item assesses the patients' ability to sit during 30 seconds without trunk and feet support and has a predictive value for recovery of walking poststroke
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Action Research Arm Test (ARAT)
Description
Assesses the patients' ability to grasp (subscale with 6 items), grip (subscale with 4 items), pinch (subscale with 6 items) and perform gross movements (subscale with 3 items) with the upper extremity. Score: 0 = no movement / 1= movement task is partially performed / 2 = movement task is completed but takes abnormally long / 3 = movement is performed normally
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Box- and Block Test (BBT)
Description
Patients (seated in front of a square box with two compartments) are asked to move as many wooden cubes as possible from one compartment to the other within 60 seconds of testing time.
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Functional Ambulation Categories (FAC)
Description
Classification (score range 0 to 5) regarding the ability to walk independently, with or without a walking aid and takes the type of walking surface into account. Rating: 0 = Patient cannot walk, or needs help from 2 or more persons = Patient needs firm continuous support from 1 person who helps carrying weight and with balance = Patient needs continuous or intermittent support of one person to help with balance and coordination = Patient requires verbal supervision or stand-by help from one person without physical contact = Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces = Patient can walk independently anywhere
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12/24/36/48/60 months +/- 30 days after randomization
Title
Change in Ten-Meter Walk Test (10MWT)
Description
Walking speed and cadence over a 10 meter track at both a comfortable and a maximum Speed; time in seconds over 10-meter walking distance
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Jamar dynamometer testing (JDT)
Description
grip strength and strength of the forearm (in kilogram)
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Montreal Cognitive Assessment (MoCA)
Description
Assesses cognitive domains: Short-term memory recall task (5 points).Visuospatial abilities assessed using clock-drawing task (3 points) and 3-dimensional cube copy (1 point). Executive functions assessed using alternation task. Attention, concentration, working memory evaluated using a sustained attention task (target detection using tapping; 1 point), serial subtraction task (3 points), digits forward and backward (1 point each). Languages assessed using 3-item confrontation naming task with low-familiarity animals (lion, camel, rhinoceros; 3 points), repetition of 2 complex sentences (2 points), and fluency task. Orientation to time and place evaluated by asking for date and city in which the test is occurring (6 points). A score of 26 or over is considered to be normal (range 0 to 30)
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Change in Daily activity measurement with movement sensor
Description
Movement sensors allow assessment of physical activity engagement and upper limb use in daily life situations without physically hampering the patient in the performance of their daily activities
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 3 months +/- 14 days after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization
Title
Rate of Serious Adverse Event (SAE)
Description
Any untoward medical occurrence that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Time Frame
Throughout the study period from Day 1 to Visit 3 ( 3 months +/- 14 days after randomization)
Title
Between-group difference of scores in the Fugl-Meyer-Motor Assessment (FMMA)
Description
FMMA is a stroke-specific impairment index designed to assess motor recovery. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale (0=cannot perform; 1=performs partially and 2= performs fully). FMMA total scores range from 0 (no movements) to 100 (normal movements) with 66 points for movements of the upper limbs (FMMA-UE) and 34 for those of the lower limbs (FMMA-LE). A difference of 5.25 points for the upper extremity and 6 points for the lower extremity part of the score are described as minimal clinically important difference. For this study, based on these data, 6 points difference are considered a patient-relevant difference between both treatment groups for the primary endpoint.
Time Frame
Assessed at Day 0 (Randomization), 5 weeks after randomization, 6 months +/- 20 days after randomization and 12 months +/- 30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute ischemic or hemorrhagic (i.e. intracerebral hemorrhage excluding subarachnoid hemorrhage and cerebal venous sinus thrombosis) stroke ≤ 7 days prior to randomization Clinically meaningful hemiparesis (i.e. scoring a total of ≥ 3 points on the following NIH stroke scale score items (i) motor arm, (ii) motor leg, (iii) limb ataxia; a distal arm paresis is equivalent to one of the aforementioned (i-iii)) Time of randomization ≥24-hours since thrombolysis or thrombectomy In-hospital rehabilitation required Capable to participate in standardized rehabilitation therapy Informed consent of patient or next of kin Exclusion Criteria: Diagnosis of Parkinson's Disease Use of Levodopa mandatory according to judgement of treating physician Inability or unwillingness to comply with study procedures including adherence to study drug intake (orally, or via nasogastric tube or percutaneous endoscopic gastrostomy tube) Severe aphasia (i.e. unable to follow two-stage-commands) Previously dependent in the basal activities of daily living (defined as modified Ranking Scale prior to stroke > 3) Pre-existing hemiparesis Known hypersensitivity to Levodopa/Carbidopa and other contraindications for Levodopa/Carbidopa as outlined in the summary of product characteristics Women who are pregnant or breast feeding, or who intend to become pregnant during the course of the study. Women of childbearing age must take a pregnancy test to be eligible for the study. Lack of safe contraception, defined as: Female Participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases. Female Participants who are surgically sterilized / hysterectomized or post- menopausal for longer than 2 years are not considered as being of child- bearing potential.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Engelter, Prof. MD
Phone
+41 61 326 4063
Email
stefan.engelter@felixplatter.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Tränka, Dr. med
Phone
+41 61 328 64 02
Email
christopher.traenka@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Engelter, Prof. MD
Organizational Affiliation
Felix-Platter Spital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Aarau, Neurozentrum
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krassen Nedeltchev, Prof. Dr. med
Phone
+41 62 838 66 75
Email
krassen.nedeltchev@ksa.ch
Facility Name
RehaClinic AG
City
Bad Zurzach
ZIP/Postal Code
5330
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Tarnutzer, PD Dr. med
Phone
+41 56 486 16 10
Email
alexander.tarnutzer@ksb.ch
Facility Name
Felix Platter Spital
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Stroke-Center Universitätsspital Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Lyrer, Prof.Dr. med
Phone
+41 61 328 61 60
Email
philippe.lyrer@usb.ch
Facility Name
Inselspital, Universitätsklinik für Neurologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René M. Müri, Prof. Dr. med
Phone
+41 31 632 30 83
Email
rene.mueri@insel.ch
Facility Name
Kantonsspital Graubünden, Departement Innere Medizin / Neurologie
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolf Sturzenegger, Dr. med
Phone
+41 81 256 73 62
Email
rolf.sturzenegger@ksgr.ch
Facility Name
HFR Fribourg Hopital Cantonal, U. de Neurologie
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Friedrich Medlin, Dr. med
Phone
+41 26 306 22 37
Email
Friedrich.Medlin@h-fr.ch
Facility Name
Centre hospitalier universitaire vaudois, Service de Neurologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrik Michel, Prof. Dr. med
Phone
+41 79 556 84 16
Email
patrik.michel@chuv.ch
Facility Name
HFR Meyriez-Murten, Clinique de Réhabilitation
City
Meyriez
ZIP/Postal Code
3280
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Kantonsspital Münsterlingen
City
Münsterlingen
ZIP/Postal Code
8596
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludwig Schelosky, Dr. med.
Phone
+41 71 686 2541
Email
ludwig.schelosky@stgag.ch
Facility Name
Reha Rheinfelden
City
Rheinfelden
ZIP/Postal Code
4310
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Hôpital du Valais - Sion, Service de neurologie
City
Sion
ZIP/Postal Code
1950
Country
Switzerland
Individual Site Status
Completed
Facility Name
Hôpital du Valais - Sion
City
Sion
ZIP/Postal Code
1950
Country
Switzerland
Individual Site Status
Completed
Facility Name
Kantonsspital St.Gallen, Klinik für Neurologie
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Kägi, Dr. med
Phone
+41 71 494 16 52
Email
georg.kaegi@kssg.ch
Facility Name
Rehazentrum Valens, Klinik für Neurologie und Neurorehabilitation
City
Valens
ZIP/Postal Code
7317
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Cereneo Schweiz AG
City
Vitznau
ZIP/Postal Code
6354
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Zürcher RehaZentrum Wald
City
Wald
ZIP/Postal Code
8636
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Rheinburg Klinik AG
City
Walzenhausen
ZIP/Postal Code
9428
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Greulich, Dr. med
Phone
+41 (0)52 266 45 60
Email
Matthias.Greulich@ksw.ch
Facility Name
Rehaklinik Zihlschlacht
City
Zihlschlacht
ZIP/Postal Code
8588
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Klinik Lengg AG
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Head Stroke Center Klinik Hirslanden
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nils Peters, Prof. Dr. med.
Phone
+41 (0)44 387 39 95
Email
nils.peters@hirslanden.ch
Facility Name
Universitätsspital Zürich, Klinik für Neurologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Luft, Prof. Dr. med
Phone
+41 44 255 54 00
Email
andreas.luft@usz.ch

12. IPD Sharing Statement

Learn more about this trial

Enhancement of Stroke Rehabilitation With Levodopa

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