Continuous Intrathecal Baclofen Infusion for Chronic Spasticity (CIBI)

This study has been withdrawn prior to enrollment.
(Study was never started. Full IDE-approval not obtained. New IDE to be submitted.)
Sponsor:
Information provided by:
Flowonix Medical
ClinicalTrials.gov Identifier:
NCT01051128
First received: January 15, 2010
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Spasticity
Device: Prometra Programmable Implantable Pump System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Intrathecal Baclofen Infusion for the Management of Chronic Spasticity

Resource links provided by NLM:


Further study details as provided by Flowonix Medical:

Primary Outcome Measures:
  • The primary endpoint is: A change in the average lower extremity spasticity score as measured by the Modified Ashworth Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Endpoints include: Change in overall spasm frequency as measured by the Penn Spasm Frequency Scale. Change in overall Quality of Life as measured by the SF 36 and PSQI. SAE-free survival. DRAE-free survival. Tabulation of device complications. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spasticity. Baclofen
This study is a non-randomized, open-label, multi-center study of the Prometra Programmable Implantable Pump System in the administration of Lioresal® intrathecal (baclofen) in patients suffering from severe muscle spasticity of spinal origin.
Device: Prometra Programmable Implantable Pump System
The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer.

Detailed Description:

The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. Lioresal Intrathecal (baclofen) is indicated for use in the management of severe spasticity. Spasticity is a major problem that has long challenged traditional medical treatment. While the incidence of spasticity is not known with certainty, it likely affects over half a million people in the United States and over 12 million worldwide. Spasticity is associated with some very common neurological disorders such as: multiple sclerosis, stroke, cerebral palsy, spinal cord and brain injuries. Chronic spasticity seriously restricts normal daily activities and reduces the quality of life for many patients.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The overall goal of this study is to choose patients most likely to experience therapeutic success while reducing the likelihood of risks, complications and adverse events.

Patients meeting all of the following criteria will be eligible for enrollment in the study:

  1. Patient with a history of severe chronic spastic hypertonia in the lower extremities lasting at least 6 months who:

    • fail to respond to maximum recommended doses of antispasmodic medications including baclofen, or
    • those who experience intolerable CNS side effects at effective oral doses
  2. Patient is >21 years of age
  3. Patient, or legally authorized representative (LAR), has provided written informed consent to participate in the study
  4. Investigator considers the patient willing and able to fulfill all study requirements
  5. Investigator has documented attempts to eliminate factors that can contribute to an increase in spasticity (e.g. infection)
  6. Patient has had a successful trial of Lioresal® for the management of the target spasticity.

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded from the study:

  1. Patient has MRI of the spine documenting structural abnormality preventing adequate CSF flow. (If the patient has a medical condition that contraindicates screening MRI, the investigator should proceed with the closest appropriate study i.e. CT scan, X-ray, to rule out any spinal abnormalities that would prevent intrathecal drug administration.)
  2. Patient's anatomy is not large enough to accommodate the pump's size and weight.
  3. Patient has a systemic infection.
  4. Patient has renal insufficiency as evidenced by a baseline serum creatinine of >2.0 mg/dl.
  5. Patient has a history of a bleeding disorder.
  6. Patient has a history of blood clots such as deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year of enrollment.
  7. Patient is pregnant or breast-feeding, or is of child-bearing potential and not employing effective birth control.
  8. Patient has known allergies or sensitivities to pump system materials (e.g., silicone rubber, titanium, polyphenylsulfone, acetal resin, polyvinylidene fluoride, tungsten).
  9. Patient has known allergies to Lioresal® (baclofen), or would be contraindicated for Lioresal® based on the drug labeling.
  10. Patient has other implantable electronic cardiac devices (i.e. pacemaker, defibrillator, CRT system)
  11. Patient has an occupation where he/she would be exposed to high current industrial equipment, powerful magnets or transmitting towers, such as, electricians, electrical engineers or MRI technicians.
  12. Patient is participating in another clinical trial.
  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: NCT01051128

Sponsors and Collaborators
Flowonix Medical
Investigators
Principal Investigator: Robert Levy, MD, PhD Northwestern University Hospital
  More Information

No publications provided

Responsible Party: Janelle Arrambide, Medasys, Incorporated
ClinicalTrials.gov Identifier: NCT01051128     History of Changes
Other Study ID Numbers: G090276
Study First Received: January 15, 2010
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Flowonix Medical:
neurological disorders
multiple sclerosis
stroke
cerebral palsy
spinal cord
brain injuries
neurodegenerative diseases

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014