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

This study is currently recruiting participants.
Verified June 2013 by CNS Therapeutics
Sponsor:
Collaborator:
Pacific-Link Regulatory Consulting LLC
Information provided by (Responsible Party):
CNS Therapeutics
ClinicalTrials.gov Identifier:
NCT01520545
First received: January 23, 2012
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Severe Spasticity
Drug: Gablofen® 3 mg/mL (baclofen injection)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Assess the Safety of 3 mg/mL Gablofen® (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed® II Programmable Infusion System

Resource links provided by NLM:


Further study details as provided by CNS Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gablofen 3 mg/mL (baclofen Injection)
3 mg/mL Gablofen (baclofen Injection)
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.
Other Name: baclofen injection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520545

Contacts
Contact: Richard E Lowenthal, MSc 858-335-1300 richard@pacificlinkconsulting.com
Contact: Tanji Goodfellow 801-783-9330 tanjig@pacificlinkconsulting.com

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Patricia Brady       bradypatriciam@uams.edu   
Principal Investigator: W. David Walters, MD, MPH         
United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92354
Contact: Murray Brandstater, MD, PhD    909-558-6277    mbrandstater@gmail.com   
Contact: Lynne Bellville    909-558-6441    lbellville@llu.edu   
Principal Investigator: Murray Brandstater, MD, PhD         
United States, Florida
Rehabilitation Medicine Department, University of Miami, Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Seema Khurana, DO    305-243-4569    skhurana@med.miami.edu   
Contact: Jorge Mejia-Galvis, FMG CRC    305-243-3575    jmejia-galvis@med.miami.edu   
Principal Investigator: Seema Khurana, DO         
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Deborah Gaebler-Spira    312-238-1149    dgaebler@rehabchicago.org   
Principal Investigator: Deborah Gaebler-Spira, MD         
United States, Michigan
Wayne State University, School of Medicine Recruiting
Dearborn, Michigan, United States, 48124
Contact: Jay Meythaler, MD       jmeythaler@med.wayne.edu   
Contact: Kristina Freese, PA-C    313-438-7373    kfreese@med.wayne.edu   
Principal Investigator: Jay Meythaler, MD         
United States, Minnesota
Gillette Children's Specialty Healthcare Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Susan Quigley, MD       squigley@gillettechildrens.com   
Contact: Susy Peters       SusyAPeters@gillettechildrens.com   
Principal Investigator: Susan Quigley, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Neil Friedman, MBChB    216-444-6772    friedmn@ccf.org   
Contact: Ellen McGannon    216-444-0173    mcganne@ccf.org   
Principal Investigator: Neil Friedman, MBChB         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Aaron L Boster, MD    614-293-6486    aaron.boster@osumc.edu   
Contact: Misty A Regula    614-293-6486      
Principal Investigator: Aaron L Boster, MD         
United States, Tennessee
Vanderbilt University Medical Center, Department of Pediatrics Recruiting
Nashville, Tennessee, United States, 37232
Contact: Steven R Couch, MD    615-936-0249    steven.couch@vanderbilt.edu   
Contact: Michelle Acton, RN    (615) 343-8972    michelle.l.acton@vanderbilt.edu   
Principal Investigator: R. Steven Couch, MD         
United States, Texas
Cook Children's Health Care System Recruiting
Fort Worth, Texas, United States, 76104
Contact: Juli Kidd, RN,CCRC    682-885-7860    juli.kidd@cookchildrens.org   
Principal Investigator: Warren Marks, MD         
TIRR Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Gerard Francisco, MD    713-799-5000    gerard.francisco@memorialhermann.org   
Contact: Shuo-Hsiu Chang, PhD    713-799-7016    Shuo-Hsiu.Chang@uth.tmc.edu   
Principal Investigator: Gerard Francisco, MD         
United States, Utah
University of Utah, Division of PM&R Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Steven Edgley, MD    801-581-4695    Steven.Edgley@hsc.utah.edu   
Contact: Brooks Castle    801-585-6998    Brooks.Castle@hsc.utah.edu   
Principal Investigator: Allison Oki, MD         
Principal Investigator: Steven Edgley, MD         
United States, Wisconsin
The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: John R McGuire, MD    414-805-7355    jmcguire@mcw.edu   
Contact: Moriah Iverson, MS    (414) 805-7341    miverson@mcw.edu   
Principal Investigator: John R McGuire, MD         
Sponsors and Collaborators
CNS Therapeutics
Pacific-Link Regulatory Consulting LLC
Investigators
Principal Investigator: Gerard Francisco, MD University of Texas
  More Information

No publications provided

Responsible Party: CNS Therapeutics
ClinicalTrials.gov Identifier: NCT01520545     History of Changes
Other Study ID Numbers: CNS-GAB101US, CNS-GAB101US
Study First Received: January 23, 2012
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CNS Therapeutics:
Gablofen
baclofen injection

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014