- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03186664
The Role of SAtivex® in Robotic-Rehabilitation (SARR)
The Role of SAtivex® Associated With Robotic-Rehabilitation in Improving the Motor Performances of Multiple Sclerosis Patients (SARR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sicily
-
Messina, Sicily, Italy, 98123
- IRCCS Centro Neurolesi Bonino-Pulejo"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion criteria were:
- age of 18-65 years,
- diagnosis of definite relapsing-remitting or primary-progressive Multiple Sclerosis, -absence of clinical relapses from no gadolinium enhanced lesions on brain and spinal cord MRI performed at least six months prior to study entry,
- no mood or sleep disorders (Hamilton score of <17),
- a moderate to severe spasticity in at least two districts of upper and/or lower limbs; -absence of clinical or neuroradiological relapses from at least six months prior to study entry,
- Expanded Disability Status Scale (EDSS) total score between 3.5 and 7.0,
- no history of psychosis,
- no presence of pace-maker, aneurysms clips, neurostimulator or brain/subdural electrodes (safety TMS procedure),
- right handedness,
- central conduction time in upper limbs of <8 ms;
- no robotic gait traing contraindications.
Exclusion Criteria:
- History of psychosis,
- presence of pace-maker, aneurysms clips, neurostimulator or brain/subdural electrodes (safety TMS procedure),
- central conduction time in upper limbs of <8 ms;
- robotic gait traing contraindications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A: Sativex+Lokomat Training
Patients Sativex responders will perform a neurorobotic-assisted gait training (RAGT, each session will last at least 45', 3 times per week, for a total amount of 20 treatment's sessions).
|
The neurorobotic treatment will be performed by using the Lokomat (Lokomat, Hocoma, Volketswil, Switzerland) device.
The work load will be progressively adjusted based on the improvement of motor performances.
Training parameters (weight support, etc) will be individually adapted.
During the first Lokomat session, support will be set at 50% of the body weight and will be adapted on observation of the gait.
The Lokomat motor guidance system will be first set at 100%, corresponding to a passive walk.
Other Names:
Patients in treatment with Sativex will receive cannabis-based medicine extract presented in a pump action sublingual spray. Sativex is composed of whole cannabis plant extract, containing THC (27 mg/mL) and CBD (25 mg/mL), in ethanol/propylene glycol (50:50) excipient. Each actuation delivers 100 KL of spray, containing THC 2.7 mg and CBD 2.5 mg. The number and frequency of dosing (sprays) with Sativex will vary from individual to individual and it may take a number of weeks to find the correct dose of Sativex for the individual patient.
Other Names:
|
Active Comparator: B: other antispastic+Lokomat Training
Patients treated with others antispastic drugs will perform a neurorobotic-assisted gait training (RAGT, each session will last at least 45', 3 times per week, for a total amount of 20 treatment's sessions).
|
The neurorobotic treatment will be performed by using the Lokomat (Lokomat, Hocoma, Volketswil, Switzerland) device.
The work load will be progressively adjusted based on the improvement of motor performances.
Training parameters (weight support, etc) will be individually adapted.
During the first Lokomat session, support will be set at 50% of the body weight and will be adapted on observation of the gait.
The Lokomat motor guidance system will be first set at 100%, corresponding to a passive walk.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Independence Measure
Time Frame: eight months
|
Contains 18 items composed of: This is divided 13 motor tasks and 5 cognitive tasks, considered basic activities of daily living) |
eight months
|
10m walking test
Time Frame: eight months
|
A tool to better define gait parameters, with regards to speed.
|
eight months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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