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

NCT01520545 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2019-05-03

No results posted yet for this study

Summary

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

Conditions

  • Severe Spasticity

Interventions

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.

DEVICE

SynchroMed® II Programmable Pump

Intrathecal programmable pump

Sponsors & Collaborators

  • Piramal Critical Care, Ltd.

    lead INDUSTRY

Principal Investigators

  • Gerard Francisco, MD · University of Texas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-08-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520545 on ClinicalTrials.gov