SISTERS: Spasticity In Stroke Study - Randomized Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Medtronic International Trading Sarl
Sponsor:
Information provided by (Responsible Party):
Medtronic International Trading Sarl
ClinicalTrials.gov Identifier:
NCT01032239
First received: December 7, 2009
Last updated: August 24, 2015
Last verified: August 2015
  Purpose

To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized 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.


Condition Intervention Phase
Severe Spasticity
Drug: intrathecal baclofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment

Resource links provided by NLM:


Further study details as provided by Medtronic International Trading Sarl:

Primary Outcome Measures:
  • Ashworth scale [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate safety by evaluating Adverse Event occurence. [ Time Frame: Baseline, 3 months, 6 months and every other visits ] [ Designated as safety issue: Yes ]
  • To evaluate the differences between ITB Therapy and BMT [ Time Frame: Baseline, 3 months, 6 months and every other visits ] [ Designated as safety issue: No ]

    The differences between ITB Therapy and BMT are evaluated through:

    1. Spasticity in the upper extremities assessed by AS
    2. Function assessed by Functional Independence Measure
    3. Function assessed by 10 meter timed walking test
    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 SF-12
    9. QoL assessed by the Stroke Specific -Quality of Life (SS-QoL)
    10. Satisfaction with the therapy assessed by Likert Scale
    11. Healthcare resource utilization


Estimated Enrollment: 88
Study Start Date: November 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ITB therapy
Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
Drug: intrathecal baclofen
ITB test, implant, 6 months follow-up
No Intervention: Best Medical Treatment (BMT)
Use one or a combination oral antispastic medication.

Detailed Description:

This is a randomized, controlled open-label parallel group study to demonstrate the efficacy benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not reached their therapy goal with other treatment interventions.

In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a two-arm parallel group design will be applied. Patients will be equally randomized to one of two treatment arms:

  1. ITB Therapy arm; or
  2. BMT arm

The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for the ITB Therapy treatment arm, followed by a 6 month active trial.

The BMT treatment arm will receive a combination of oral antispastic medication and physiotherapy. Patients must be prescribed at least one or a combination of the following oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines) or dantrolene. Following the run-in phase, patients will enter the 6 month active trial.

The ITB Therapy treatment arm will receive a combination of ITB Therapy and physiotherapy. During the run-in phase, a test with intrathecal baclofen will be performed to evaluate the response of the patient. Patients fulfilling the test success criterium will be implanted with a Medtronic SynchroMed®II infusion system. Following implant, patients will enter into the 6 month active trial, which includes a 6 week titration phase, during which time oral antispastic medications must be gradually reduced with complete discontinuation by the end of the titration period.

During the 6 month active trial, patients will be assessed at 3 and 6 months. All primary and secondary endpoint assessments will be performed by a blinded assessor.

The total study duration is expected to be 60 months, including a 39 month enrollment period. The total duration per patient is approximately 7 months (approximately 1 month run-in period followed by 6 months active treatment).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. patient experienced last stroke > 6 months prior to enrollment
  3. patient presents spasticity in at least 2 extremities
  4. patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle groups in the lower extremities
  5. patient is eligible to receive ITB Therapy following the Adult Spasticity Algorithm. A patient does not reach his/her therapy goal with other treatment interventions
  6. stable blood pressure: no change in hypertensive medication in last month (NOTE: ventriculoperitoneal shunts and valves can be present)
  7. if female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
  8. patient/family is willing to comply with study protocol including attending the study visits

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 patient can switch to another accepted anticoagulant (e.g. heparin, aggrenox, fragmin, plavix, ticlid) for the period of ITB test and implant
  7. patient is pregnant or breastfeeding
  8. patient received a Botulinum toxin injection less than 4 months ago
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032239

Contacts
Contact: Nathalie Berthuy +41 218038564 nathalie.berthuy@medtronic.com
Contact: Alessandra Calabrese +41 21 803 8160 alessandra.calabrese@medtronic.com

  Show 26 Study Locations
Sponsors and Collaborators
Medtronic International Trading Sarl
Investigators
Principal Investigator: Leopold SALTUARI, Prof. Landeskrankenhaus Hochzirl, Zirl (Austria)
  More Information

No publications provided

Responsible Party: Medtronic International Trading Sarl
ClinicalTrials.gov Identifier: NCT01032239     History of Changes
Other Study ID Numbers: 1.02.7001
Study First Received: December 7, 2009
Last Updated: August 24, 2015
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Ministry of Health and Consumption
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board

Keywords provided by Medtronic International Trading Sarl:
Severe spasticity in post-stroke patients

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 03, 2015