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A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
This study is currently recruiting participants.
Verified by IMPAX Laboratories, Inc., September 2009
First Received: June 2, 2009   Last Updated: September 21, 2009   History of Changes
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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Nighttime Awakening Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: April 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IPX056: Experimental Drug: IPX056
Encapsulated IPX056
Baclofen: Active Comparator Drug: Baclofen
Encapsulated baclofen capsule

  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 Recruiting
Tucson, Arizona, United States, 85741
Contact: IPX056-B09-01 Study Coordinator     520-742-1833        
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: IPX056-B09-01 Study Coordinator     303-724-2198        
United States, Florida
Meridien Research Recruiting
Tampa, Florida, United States, 33606
Contact: IPX056-B09-01 Study Coordinator     813-877-8839        
United States, Indiana
Fort Wayne Neurological Center Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: IPX056-B09-01 Study Coordinator     260-460-3257        
United States, Kansas
MidAmerica Neuroscience Institute Recruiting
Lenexa, Kansas, United States, 66214
Contact: IPX056-B09-01 Study Coordinator     913-894-1500 ext 166        
United States, Michigan
QUEST Research Institute Recruiting
Bingham Farms, Michigan, United States, 48025
Contact: IPX056-B09-01 Study Coordinator     248-644-7770        
United States, Montana
Great Falls Cllinic Recruiting
Great Falls, Montana, United States, 59405
Contact: IPX056-B09-01 Study Coordinator     406-268-3923        
United States, New York
Empire Neurology, PC Recruiting
Latham, New York, United States, 12110
Contact: IPX056-B09-01 Study Coordinator     802-447-7577        
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: IPX056-B09-01 Study Coordinator     516-663-9582        
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: IPX056-B09-01 Study Coordinator     336-716-1704        
United States, Texas
Central Texas Neurology Consultants Recruiting
Round Rock, Texas, United States, 78681
Contact: IPX056-B09-01 Study Coordinator     512-218-1222        
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 Laboratories ( Impax Pharmaceuticals, a division of Impax Laboratories )
Study ID Numbers: IPX056-B09-01
Study First Received: June 2, 2009
Last Updated: September 21, 2009
ClinicalTrials.gov Identifier: NCT00914290     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 08, 2010