Severe spasticity in post-stroke patients MedDRA version: 18.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Lioresal Intrathecal
Product Name: Lioresal Intrathecal
Pharmaceutical Form:
INN or Proposed INN: BACLOFEN
CAS Number: 1134-47-0
Current Sponsor code: NA
Other descriptive name: NA
Concen
Sponsors
Medtronic International Trading Sarl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment: 1. patient (or legal guardian) has been informed of the study procedures and has given written informed consent 2. 18-75 years of age 3. patient experienced last stroke > 6 months prior to enrollment 4. patient presents spasticity in at least 2 extremities 5. patient presents an Ashworth score = 3 in a minimum of two of the af-fected muscle groups in the lower extremities 6. patient is eligible to receive ITB Therapy following the Adult Spasticity Al-gorithm a. patient does not reach his/her therapy goal with other treatment in-terventions 7. stable blood pressure: a. no change in hypertensive medication in last month (NOTE: ventriculo-peritoneal shunts and valves can be present) 8. if female, she must either a. be post-menopausal or surgically sterilized; or b. use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study 9. patient/family is willing to comply with study protocol including attending the study visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for inclusion in this study the patients must not meet any of the following criteria: 1. patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management 2. patient has known hypersensitivity to baclofen 3. active systemic infection (NOTE: pressure sores are not a contraindication unless they are present near the implant sites) 4. presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device 5. uncontrolled refractory epilepsy 6. use of oral vitamin K antagonists, e.g. warfarin/coumadin; unless the pa-tient can switch to another accepted anticoagulant (e.g. heparin, aggre-nox, fragmin, plavix, ticlid) for the period of ITB test and implant 7. patient is pregnant or breast-feeding 8. patient received a Botulinum toxin injection less than 4 months ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Intrathecal Baclofen Therapy (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with genera-lized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.;Secondary Objective: To evaluate safety (Adverse Events (AE)) in ITB Therapy and BMT. To evaluate the differences between ITB Therapy and BMT on: 1. Spasticity in the upper extremities assessed by AS 2. Function assessed by Functional Independence Measure (FIM) 3. Function assessed by 10 meter timed walking test (10MTWT; High Level Functional Patients only) 4. Function assessed by ability to transfer 5. Pain assessed by Numeric Pain Rating Scale (NPRS) 6. Primary therapy goal achievement assessed by Goal Attainment Scale (GAS) 7. Quality of Life (QoL) assessed by EuroQol group – 5 Dimensional (EQ-5D) 8. QoL assessed by the Stroke Specific – Quality of Life (SS-QoL) 9. Satisfaction with the therapy assessed by Likert Scale (patient and ca-regiver) 10. Healthcare resource utilization ;Primary end point(s): The average AS will be calculated as an average of the AS value on following lower extremeties muscles: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Change in the average AS from baseline to 6 months visit. | — |
Countries
Austria, Belgium, Germany, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactNathalie Berthuy
Medtronic International Trading Sarl
Outcome results
None listed