Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt; Piramal Critical Care, Ltd.
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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