Status:
COMPLETED
Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump
Lead Sponsor:
Piramal Critical Care, Ltd.
Conditions:
Severe Spasticity
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump
Detailed Description
This is a prospective 36-month Phase IIIb/IV clinical safety trial that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. All patients will be entere...
Eligibility Criteria
Inclusion
- 4 years of age or older
- Subjects must be clinically diagnosed with sever spasticity and be receiving intrathecal baclofen
- Subjects must have a SynchroMed® II Pump already implanted
- Current treatment with intrathecal baclofen should be at the 2 mg/mL concentration
- Life expectancy greater than or equal to 12 months
- Signed written informed consent
- Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures
Exclusion
- History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which is allowed
- History of any allergic reaction to baclofen
- History of inflammatory granulomas with an intrathecal infusion pump
- Any previous history of neuroleptic malignant syndrome or malignant hyperthermia
- As a result of medical review and physical examination, the Investigator considers the subject unfit for the study
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01520545
Start Date
December 1 2012
End Date
October 1 2016
Last Update
May 3 2019
Active Locations (13)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Loma Linda University
Loma Linda, California, United States, 92354
3
Rehabilitation Medicine Department, University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
4
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611