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

Severe Spasticity research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Severe Spasticity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gablofen® 3 mg/mL (baclofen injection)This is a prospective twelve-month Phase IIIb clinical safety trial followed by a 2-year, Phase IV study that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. Patients will be followed for the duration of their treatment with Gablofen® (baclofen injection) 3 mg/mL using the SynchroMed® II Programmable Pump or until the study is terminated.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Gablofen 3 mg/mL (baclofen Injection)3 mg/mL Gablofen (baclofen Injection)

Study Status

Completed

Start Date: December 2012

Completed Date: October 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.

Secondary Outcome: Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration

Study sponsors, principal investigator, and references

Principal Investigator: Gerard Francisco, MD

Lead Sponsor: Piramal Critical Care, Ltd.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01520545

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