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A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00914290
First received: June 2, 2009
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).

Condition Intervention Phase
Spasticity
Multiple Sclerosis
Drug: IPX056
Drug: Baclofen IR
Drug: Placebo IPX056
Drug: Placebo IR
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • Morning Stiffness Score [ Time Frame: 6 weeks ]

Enrollment: 23
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IPX056-Baclofen IR-IPX056
Following 2 weeks of run-in period, subjects were randomized to IPX056 and Placebo IR for 2 weeks and then to Baclofen IR and Placebo IPX056 for 2 weeks.
Drug: IPX056
IPX056 ER capsule containing 10 mg baclofen
Other Names:
  • IPX056 ER Capsule
  • IPX056 ER
Drug: Baclofen IR
Encapsulated baclofen tablet 5 mg per capsule
Other Name: CAS Registry Number [11134-47-0]
Drug: Placebo IPX056
Placebo capsule for IPX056
Drug: Placebo IR
Placebo encapsulated baclofen placebo tablet
Active Comparator: IPX056-IPX056-Baclofen IR
Following 2 weeks of run-in period, subjects were randomized to Baclofen IR and Placebo IPX056 for 2 weeks and then to IPX056 and Placebo IR for 2 weeks.
Drug: IPX056
IPX056 ER capsule containing 10 mg baclofen
Other Names:
  • IPX056 ER Capsule
  • IPX056 ER
Drug: Baclofen IR
Encapsulated baclofen tablet 5 mg per capsule
Other Name: CAS Registry Number [11134-47-0]
Drug: Placebo IPX056
Placebo capsule for IPX056
Drug: Placebo IR
Placebo encapsulated baclofen placebo tablet

Detailed Description:
IPX056 was compared with commercially available tablets as it was designed to provide a prolonged duration of absorption to reduce dose frequency and/or to provide prolonged duration of antispasticity effect.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 18 years old.
  • Agrees to use a medically acceptable method of contraception throughout the study
  • Diagnosed with MS as defined by Poser or McDonald Criteria.
  • Receiving commercial baclofen tablets at a stable total daily dose ranging from 15 mg to 80 mg in a TID dosing regimen for at least 4 weeks prior to the Screening Visit that has resulted in improved spasticity.
  • Willing to wash out and remain off other antispasticity medications during the study.

Exclusion Criteria:

  • If female, the subject is pregnant, planning to become pregnant, or breastfeeding.
  • History of allergy or severe intolerance to baclofen.
  • Did not respond to previous baclofen treatment in any formulation.
  • Has experienced an exacerbation of MS within 1 month.
  • Urinary tract infection (UTI) within 2 weeks or two symptomatic UTIs within 6 months prior to the study.
  • Subjects with clinically significant impairment of renal function
  • History of active seizure disorder or epilepsy, or currently taking an anticonvulsant for treatment or control of seizure.
  • Other conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g. Parkinson's Disease).
  • Treated with Botulinum Toxin Type A or B within the previous 4 months, or with phenol or therapeutic alcohol nerve block within 12 months or planned use of these drugs during this study.
  • Has clinically significant limitation of passive range of motion of lower extremities.
  • Has had major surgery within 6 months prior to Screening Visit that may affect spasticity assessments such as abdominal surgery, back surgery, lower leg and 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: NCT00914290

Locations
United States, Arizona
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States, 85741
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Meridien Research
Tampa, Florida, United States, 33606
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46805
United States, Kansas
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Michigan
QUEST Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Montana
Great Falls Cllinic
Great Falls, Montana, United States, 59405
United States, New York
Empire Neurology, PC
Latham, New York, United States, 12110
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: Impax Study Director Impax Laboratories (Impax Pharmaceuticals, a division of Impax Laboratories)
  More Information

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00914290     History of Changes
Other Study ID Numbers: IPX056-B09-01 
Study First Received: June 2, 2009
Last Updated: January 31, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Muscle Spasticity
Pathologic Processes
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

ClinicalTrials.gov processed this record on February 20, 2017