Severe SpasticityPhase 3NCT01520545
Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump
A Phase 3 study testing Gablofen® 3 mg/mL (baclofen injection) and SynchroMed® II Programmable Pump in people with Severe Spasticity, run by Piramal Critical Care, Ltd. at 13 sites in United States.
Trial summary
Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Severe Spasticity
- What is being tested?
- Gablofen® 3 mg/mL (baclofen injection) and SynchroMed® II Programmable Pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2012to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43221
Wayne State University, School of Medicine
Dearborn, Michigan, 48124
Cook Children's Health Care System
Fort Worth, Texas, 76104
TIRR Memorial Hermann
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Loma Linda University
Loma Linda, California, 92354
Rehabilitation Medicine Department, University of Miami, Miller School of Medicine
Miami, Florida, 33136
The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center, Department of Pediatrics
Nashville, Tennessee, 37232
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
University of Utah, Division of PM&R
Salt Lake City, Utah, 84132
About this study
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
Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump
Read the 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.
- Conditions
- Severe Spasticity
- Being tested
- Gablofen® 3 mg/mL (baclofen injection), SynchroMed® II Programmable Pump
- Keywords
- Gablofen, baclofen injection
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gablofen® 3 mg/mL (baclofen injection)Drug
Also called 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.
SynchroMed® II Programmable PumpDevice
Intrathecal programmable pump
| Study group | Role | What they receive |
|---|---|---|
| Gablofen 3 mg/mL (baclofen Injection) | Experimental | 3 mg/mL Gablofen (baclofen Injection) Receives: Drug: Gablofen® 3 mg/mL (baclofen injection); Device: SynchroMed® II Programmable Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36-months
Secondary outcomes (1)
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
Measured: 36-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Critical Care, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Francisco, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520545
- Sponsor's protocol ID
- CNS-GAB101US
- Status last verified
- Apr 2019
- First submitted
- 23 Jan 2012
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01520545
- Acronym / sponsor ID
- CNS-GAB101US
- Conditions
- Severe Spasticity
- Keywords
- Gablofen, baclofen injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Piramal Critical Care, Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gablofen 3 mg/mL (baclofen Injection) | Experimental | Drug: Gablofen® 3 mg/mL (baclofen injection), Device: SynchroMed® II Programmable Pump3 mg/mL Gablofen (baclofen Injection) |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gablofen® 3 mg/mL (baclofen injection)Also: baclofen injectionThis 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. | Drug | Gablofen 3 mg/mL (baclofen Injection) |
| SynchroMed® II Programmable PumpIntrathecal programmable pump | Device | Gablofen 3 mg/mL (baclofen Injection) |
Primary outcome
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.
1 secondary outcome
Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration
Time frame: 36-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Francisco, MD principal investigator
University of Texas
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gablofen® 3 mg/mL (baclofen injection) and SynchroMed® II Programmable Pump in people with Severe Spasticity, run by Piramal Critical Care, Ltd. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.