Phase 4 N=60 Randomized Treatment

SISTERS: Spasticity In Stroke Study - Randomized Study

Severe Spasticity

Bottom Line

View on ClinicalTrials.gov: NCT01032239 ↗

Enrolled (actual)

Serious AEs

36.7%

Results posted

Feb 2018

Primary outcome: Primary: Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 — -0.99; -0.43 units on a scale — p=0.0140

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: intrathecal baclofen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MedtronicNeuro
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6	-0.99; -0.43	0.0140 sig
SECONDARY Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6	-0.66; -0.17	0.0042 sig
SECONDARY Change in Functional Independence Measure (FIM) Score From Baseline to Month 6	2.68; -2.58	0.0540
SECONDARY Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6	4.86; -2.48	0.6256
SECONDARY Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance	22; 24; 9; 5; 19; 21	0.3676
SECONDARY Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6	-1.17; 0.00; -1.61; 0.24; -1.35; -0.04	0.0380 sig
SECONDARY Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS)	10; 8; 14; 16	0.7661
SECONDARY Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6	0.09; 0.01; 9.68; 4.40	0.0197 sig
SECONDARY Change in SF-12 (12-item Short Form) From Baseline to Month 6	3.13; -1.13; 1.05; -0.82	0.1068
SECONDARY Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6	0.26; 0.05	0.2105
SECONDARY Therapy Satisfaction	2; 7; 4; 5; 16; 11	—
SECONDARY Healthcare Resource Utilization	14; 8; 4; 8; 1; 0	—

Summary

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.

Eligibility Criteria

Inclusion criteria

To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment:

patient (or legal guardian) has been informed of the study procedures and has given written informed consent
patient experienced last stroke > 6 months prior to enrollment
patient presents spasticity in at least 2 extremities
patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle groups in the lower extremities
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
stable blood pressure: no change in hypertensive medication in last month (NOTE: ventriculoperitoneal shunts and valves can be present)
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
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:

patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management
patient has known hypersensitivity to baclofen
active systemic infection (NOTE: pressure sores are not a contraindication unless they are present near the implant sites)
presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device
uncontrolled refractory epilepsy
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
patient is pregnant or breastfeeding
patient received a Botulinum toxin injection less than 4 months ago

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01032239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.