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Completed

NCT Number: NCT01520545

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

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

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Key information

Conditions

Severe Spasticity Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gablofen® 3 mg/mL (baclofen injection)

Drug

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.

Other names: baclofen injection

SynchroMed® II Programmable Pump

Device

Intrathecal programmable pump

Primary outcomes

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

    Time frame: 36-months

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

Secondary outcomes

  1. Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration

    Time frame: 36-months

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

Sponsors and collaborators

Lead sponsor

Piramal Critical Care, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2012
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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