Continuous Intrathecal Baclofen Infusion for Chronic Spasticity

Spasticity Clinical Trial

— CIBI  

Official title:

Continuous Intrathecal Baclofen Infusion for the Management of Chronic Spasticity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01051128
• Other study ID #: G090276
• Status: Withdrawn
• Phase: Phase 3
• First received: January 15, 2010
• Last updated: March 5, 2015
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2015
• Source: Flowonix Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Flowonix Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is: A change in the average lower extremity spasticity score as measured by the Modified Ashworth Scale		3 months	No
Secondary	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	Yes