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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00914290
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Impax Laboratories, LLC

Brief Summary:
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).

Condition or disease Intervention/treatment Phase
Spasticity Multiple Sclerosis Drug: IPX056 Drug: Baclofen IR Drug: Placebo IPX056 Drug: Placebo IR Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
Study Start Date : April 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
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




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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914290


Locations
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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, LLC
Investigators
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Study Director: Impax Study Director Impax Laboratories, LLC
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Responsible Party: Impax Laboratories, LLC
ClinicalTrials.gov Identifier: NCT00914290    
Other Study ID Numbers: IPX056-B09-01
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Multiple Sclerosis
Sclerosis
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
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action