NCT01032239 (SISTERS) is a Phase 4 clinical trial of intrathecal baclofen in Severe Spasticity, sponsored by MedtronicNeuro.

Who is sponsoring NCT01032239?

NCT01032239 is sponsored by MedtronicNeuro.

What drugs are being tested in NCT01032239?

Interventions in NCT01032239: intrathecal baclofen.

What condition does NCT01032239 study?

NCT01032239 studies Severe Spasticity.

Is NCT01032239 still recruiting?

NCT01032239 is currently completed. Last updated 18 January 2018.

Are results published for NCT01032239?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-01-18 · How we verify

NCT01032239: SISTERS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 18 January 2018

What this trial tests

Phase 4 trial testing intrathecal baclofen in Severe Spasticity in 61 participants. Completed in 1 September 2016.

Timeline

1 November 2009

Primary endpoint
1 September 2016

1 September 2016

Quick facts

Lead sponsor	MedtronicNeuro
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	1 November 2009
Primary completion	1 September 2016
Estimated completion	1 September 2016
Sites	25 locations across United States, Austria, Belgium, Germany, Italy, Netherlands, Slovenia, Spain

Drugs / interventions tested

intrathecal baclofen — full drug profile →

Conditions studied

Severe Spasticity — all drugs for Severe Spasticity →

Sponsor

MedtronicNeuro — full company profile →

Who can join

Adults 18 to 75, any sex, with Severe Spasticity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6
Time frame: Baseline and month 6
AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS).
Creamer M, Cloud G, Kossmehl P, Yochelson M, et al · · 2018 · cited 34× · PMID 29326296 · DOI 10.1136/jnnp-2017-317021
Effect of Intrathecal Baclofen on Pain and Quality of Life in Poststroke Spasticity.
Creamer M, Cloud G, Kossmehl P, Yochelson M, et al · · 2018 · cited 31× · PMID 30354975 · DOI 10.1161/strokeaha.118.022255
European Stroke Organisation Conference: Abstracts
· 2018

Verify or expand the search:

Other MedtronicNeuro trials

Trials by the same sponsor.

NCT05775510 — Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chro · terminated
NCT05226286 — Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2) · NA · completed
NCT05200923 — Pelvic Health Electrically Evoked Recording (PEER) 2 Study · NA · recruiting
NCT05177354 — Medtronic Closed-Loop Spinal Cord Stimulation System · NA · completed
NCT07106242 — Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01032239 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedtronicNeuro
Last refreshed: 18 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01032239.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing