Continuous Intrathecal Baclofen Infusion for Chronic Spasticity

NCT01051128 | Withdrawn Phase 3

• 1 other identifier: G090276
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spasticity

Keywords

neurological disorders; multiple sclerosis; stroke; cerebral palsy; spinal cord; brain injuries; neurodegenerative diseases

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is: A change in the average lower extremity spasticity score as measured by the Modified Ashworth Scale

  3 months

Secondary Outcomes (1)

• 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.

  3 months

Study Arms (1)

Spasticity. Baclofen

EXPERIMENTAL

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

Interventions

Prometra Programmable Implantable Pump System DEVICE

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.

Spasticity. Baclofen

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• Patient is \>21 years of age
• Patient, or legally authorized representative (LAR), has provided written informed consent to participate in the study
• Investigator considers the patient willing and able to fulfill all study requirements
• Investigator has documented attempts to eliminate factors that can contribute to an increase in spasticity (e.g. infection)
• Patient has had a successful trial of Lioresal® for the management of the target spasticity.

You may not qualify if:

• Patients meeting any of the following criteria are to be excluded from the study:
• 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.)
• Patient's anatomy is not large enough to accommodate the pump's size and weight.
• Patient has a systemic infection.
• Patient has renal insufficiency as evidenced by a baseline serum creatinine of \>2.0 mg/dl.
• Patient has a history of a bleeding disorder.
• Patient has a history of blood clots such as deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year of enrollment.
• Patient is pregnant or breast-feeding, or is of child-bearing potential and not employing effective birth control.
• Patient has known allergies or sensitivities to pump system materials (e.g., silicone rubber, titanium, polyphenylsulfone, acetal resin, polyvinylidene fluoride, tungsten).
• Patient has known allergies to Lioresal® (baclofen), or would be contraindicated for Lioresal® based on the drug labeling.
• Patient has other implantable electronic cardiac devices (i.e. pacemaker, defibrillator, CRT system)
• 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.
• Patient is participating in another clinical trial.

Sponsors & Collaborators

• Flowonix Medical: lead

MeSH Terms

Conditions

Muscle Spasticity; Nervous System Diseases; Multiple Sclerosis; Stroke; Cerebral Palsy; Brain Injuries; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Robert Levy, MD, PhD

  Northwestern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 6, 2015

Record last verified: 2015-03