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

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

Detailed Description
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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 entered after signing an IRB approved informed consent. 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. Patients will be evaluated for clinical complications associated with the use of intrathecal baclofen that are considered signs and symptoms of an inflammatory granuloma, specifically new radicular pain at the level of the catheter tip, and/or spinal cord compression. An MRI scan with and without infusion will be performed (with consent of the patient) to evaluate the potential presence of an inflammatory granuloma if clinical signs exist. Events that may be related to an inflammatory granuloma will be classified as a definite granuloma, possible granuloma, other catheter related problem (confirmed not caused by a granuloma), or other clinical sequelae caused by the underlying disease or other infusion system related event.

Official Title
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Study to Assess the Safety of 3 mg/mL Gablofen® (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed® II Programmable Infusion System

Conditions
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Severe Spasticity

Intervention / Treatment
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* Drug: Gablofen® 3 mg/mL (baclofen injection)
* Device: SynchroMed® II Programmable Pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gablofen 3 mg/mL (baclofen Injection)<br>3 mg/mL Gablofen (baclofen Injection) | Drug: Gablofen® 3 mg/mL (baclofen injection)<br>* 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.<br>* Other names: baclofen injection;Device: SynchroMed® II Programmable Pump<br>* Intrathecal programmable pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration. | The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration. | 36-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration | Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration | 36-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gablofen, baclofen injection