A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis - Full Text View

Sponsor:	IMPAX Laboratories, Inc.
Information provided by:	IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00914290

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	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Baclofen

U.S. FDA Resources

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

Primary Outcome Measures:

Morning Stiffness Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Nighttime Awakening Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
Experimental: IPX056	Drug: IPX056 Encapsulated IPX056 Other Names: IPX056 ER Capsule IPX056 ER
Active Comparator: Baclofen	Drug: Baclofen Encapsulated baclofen capsule Other Names: CAS Registry Number [11134-47-0] C10H12ClNO2

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

No publications provided

Responsible Party:	Impax Pharmaceuticals, a division of Impax Laboratories, Impax Laboratories
ClinicalTrials.gov Identifier:	NCT00914290 History of Changes
Other Study ID Numbers:	IPX056-B09-01
Study First Received:	June 2, 2009
Last Updated:	March 29, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Sclerosis
Muscle Spasticity
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
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 May 23, 2012