Trial record 12 of 68 for:    Open Studies | "Muscle Spasticity"

Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01457352
First received: October 17, 2011
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to assess whether baclofen ER capsules demonstrate efficacy and safety in the treatment of spasticity.


Condition Intervention Phase
Spasticity
Drug: Baclofen ER Capsules
Drug: Placebo GRS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Randomized Withdrawal Evaluation of the Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
  • Determining the safety profile when administered over >12 weeks [ Time Frame: Week 22 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subject Global Impression of Severity (SGIS)assessment [ Time Frame: Week 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baclofen ER Capsules
Subjects will receive open-label Baclofen ER Capsules (GRS), as a single capsule (unless otherwise noted) for up to 16 weeks in an open-label fashion and Baclofen ER Capsules (GRS) or placebo in a double-blind fashion for up to an additional 4 weeks, consistent with the down-titration schedule.
Drug: Baclofen ER Capsules
Subjects will receive open-label Baclofen ER Capsules (GRS), as a single capsule (unless otherwise noted) for up to 16 weeks in an open-label fashion and Baclofen ER Capsules (GRS) or placebo in a double-blind fashion for up to an additional 4 weeks, consistent with the down-titration schedule
Other Name: Baclofen ER
Placebo Comparator: Placebo GRS
All subjects randomized to the placebo arm will receive Placebo GRS.
Drug: Placebo GRS
All subjects randomized to the placebo arm will receive Placebo GRS.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18 years and older
  • Women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives, bilateral tubal ligation or vasectomized partner] for at least 3 months prior to study entry OR postmenopausal for at least 1 year OR surgically sterile (bilateral oophorectomy or hysterectomy)
  • If female, negative pregnancy test
  • Known history of spasticity due to MS prior to starting baclofen
  • A stable daily dose of Baclofen IR, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for last 30 days)
  • Able and willing to comply with the protocol, including availability for a scheduled clinic visits
  • Willingness and giving of written informed consent

Exclusion Criteria:

  • History of hypersensitivity to baclofen
  • In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
  • Concomitant neurologic conditions causing spasticity
  • Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
  • Unable to comply with study procedures in the opinion of the investigator
  • Has had major surgery within 3 months prior to Screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, or lower leg or knee surgeries
  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: NCT01457352

Contacts
Contact: Shravanti Bhowmik, MD +9122 66455645 ext 626 Shravanti.Bhowmik@sparcmail.com

  Show 25 Study Locations
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Investigators
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Centre Ltd, India
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01457352     History of Changes
Other Study ID Numbers: CLR_09_21
Study First Received: October 17, 2011
Last Updated: April 23, 2013
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 September 14, 2014