A Clinical Evaluation Of The Safety Of Baclofen Er Capsules (Grs) When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (Ms): An Open Label, Long Term, Safety Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01797185
First received: February 16, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This is a multicenter, open-label, safety trial in subjects with spasticity due to MS. Approximately 200 subjects will be enrolled in approximately 30-35 centers, in order to obtain safety data from at least 100 subjects who have completed at least 26 weeks of treatment. An attempt will be made to enroll at least 20 subjects who will be baclofen-naïve at entry.

Subjects enrolled in clinical trial CLR_09_21 who complete the double-blind randomized withdrawal phase (Part 3) of that trial will be eligible to participate in this trial. In addition, subjects not enrolled in trial CLR_09_21 who are on a stable daily dose (same total daily dose of baclofen for at least 30 days prior to enrollment) of baclofen immediate release (IR), as well as baclofen-naïve subjects will be eligible to participate in this trial.

Subjects enrolled in this trial who did not participate in CRL_09_21 will receive open label Baclofen ER Capsules (GRS). Subjects who enroll in this trial and participated in the double-blind phase of study CRL_09_21 will temporarily receive blinded study medication during the first 4 weeks which will be dispensed using an electronic drug-dispensing system (IVRS/IWRS).


Condition Intervention Phase
Spasticity
Drug: Baclofen
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A CLINICAL EVALUATION OF THE SAFETY OF BACLOFEN ER CAPSULES (GRS) WHEN ADMINISTERED ONCE DAILY TO SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS (MS): AN OPEN LABEL, LONG TERM, SAFETY TRIAL

Resource links provided by NLM:


Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • No. of participants with adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • No. of participants with adverse vital signs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse laboratory parameters [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baclofen ER
The subjects will receive Baclofen capsules
Drug: Baclofen

Subjects enrolled following the completion of protocol CLR_09_21 will receive daily doses of Baclofen ER Capsules (GRS) as follows:

  • Subjects who were randomized to Baclofen ER Capsules (GRS) in the double-blind part of study CLR_09_21 (Part 3) will continue to receive the same dose of baclofen as they received in study CLR_09_21.
  • Subjects who were randomized to placebo in the double-blind part of study CLR_09_21 (Part 3), will receive Baclofen ER Capsules (GRS) at a starting dose of 10 mg/day, titrated in 10 mg increments every 3 days up to the dose of Baclofen ER Capsules (GRS) that they received in open-label fixed GRS dose phase (Part 2) of study CLR_09_21.

Subjects enrolled in this study who participated in the double-blind phase of study CLR_09_21 will temporarily receive blinded study medication in the first 4 weeks dispensed according to the IVRS/IWRS.


Detailed Description:

All subjects will undergo safety assessments at Screening (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), Week 12 (Visit 4), Week 26 (Visit 5) and all follow-up visits conducted every three months

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Willingness to participate and give written informed consent
  • Men and women ≥ 18 years of age
  • Sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. Examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. The practice of contraception must have started at least 3 months prior to trial entry.
  • If female, negative pregnancy test result at Screening
  • Diagnosed with MS and a known history of spasticity
  • Meet one of the following criteria

    • Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation
    • Subjects who are newly diagnosed with spasticity due to MS with no history of treatment using any anti-spasticity medications, or, with a history of spasticity due to MS but with no previous exposure to baclofen treatment
    • Subjects who are receiving a stable baclofen IR dose (ie, a dose of 10 mg to 80 mg daily, having started at least 30 days prior to enrollment)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797185

  Show 49 Study Locations
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Investigators
Principal Investigator: Brian a Peterson, CCRC
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01797185     History of Changes
Other Study ID Numbers: CLR_11_04, CLR_11_04
Study First Received: February 16, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sun Pharma Advanced Research Company Limited:
baclofen, spasticity

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

ClinicalTrials.gov processed this record on August 28, 2014