E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language | Increased muscle tension in people with spinal cord injury | |
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | The aim of the study is to test the effectiveness of Methocarbamol in the treatment of spasticity after spinal cord injury. | |
E.2.2 | Secondary objectives of the trial | To facilitate the rehabilitation process | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | • a history of spinal cord injury; • the presence of increased muscle tension on the Ashwort scale 2 to 4; • time since injury: 3 months; • the patient must be circulatory and respiratory efficient, alert and aware; adapted to a vertical position; • a patient with complete and incomplete spinal cord injury, in the cervical, thoracic and lumbar spine, in whom the flexion and extension function will be maintained in the elbow and wrist joints; • preserved spine stabilization, stabilization of the anastomosis after surgery, completed bone union; • no contraindications to rehabilitation, such as thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection. | |
E.4 | Principal exclusion criteria | • the patient's use of a myorelaxant other than methocarbamol; • the patient's use of botulinum toxin; • tetraplegia; • joint contractures preventing rehabilitation with robots and other contraindications to robotic therapy, such as severe osteoporosis, circulatory and respiratory system disorders, skin lesions, thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection; • the presence of open, oozing bedsores; • malnutrition, wasting of the body (muscle atrophy of the paralyzed without signs of malnutrition and wasting of the body are not the cause of exclusion); • lack of the patient's informed consent; • pregnancy or breast-feeding. | |
E.5 End points |
E.5.1 | Primary end point(s) | For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV. The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle. | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV. The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle. | |
E.5.2 | Secondary end point(s) | The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement. The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared: - distance covered by the patient in a unit of time; - guiding force - the support force from the robot that the patient needed for proper gait. | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement. The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared: - distance covered by the patient in a unit of time; - guiding force - the support force from the robot that the patient needed for proper gait. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 | The trial involves single site in the Member State concerned | Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |