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NCT01051128: CIBI
Continuous Intrathecal Baclofen Infusion for the Management of Chronic Spasticity
Phase 3 trial testing Prometra Programmable Implantable Pump System in Spasticity. Withdrawn.
1 June 2010
Quick facts
| Lead sponsor | Flowonix Medical |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 January 2010 |
| Primary completion | 1 June 2010 |
| Estimated completion | 1 December 2010 |
Drugs / interventions tested
- Prometra Programmable Implantable Pump System
Conditions studied
- Spasticity — all drugs for Spasticity →
Sponsor
Flowonix Medical
Who can join
22 and older, any sex, with 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.
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The primary endpoint is: A change in the average lower extremity spasticity score as measured by the Modified Ashworth Scale
Time frame: 3 months
Sponsor's own description
The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Latest approaches for the treatment of spasticity and autonomic dysreflexia in chronic spinal cord injury.
Rabchevsky AG, Kitzman PH. · · 2011 · cited 62× · PMID 21384222 · DOI 10.1007/s13311-011-0025-5
Verify or expand the search:
- PubMed search for NCT01051128
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Spasticity
Currently open trials in the same condition.
- NCT05926596 — Leg Stretching Using an Exoskeleton on Demand for People With Spasticity · NA · recruiting
- NCT07466823 — Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple · recruiting
- NCT07273591 — Effects of Low-level Laser Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Plantar Fle · NA · recruiting
- NCT06811142 — Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence · EARLY_PHASE1 · active not recruiting
- NCT06782464 — Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder · NA · recruiting
Other Flowonix Medical trials
Trials by the same sponsor.
- NCT01854229 — Prometra Post-Approval Study · 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)
- Trial protocol + status: ClinicalTrials.gov NCT01051128 (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 Flowonix Medical
- Last refreshed: 5 March 2015
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/NCT01051128.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing