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

This study has been completed.
Sponsor:
Information provided by:
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00914290
First received: June 2, 2009
Last updated: March 29, 2010
Last verified: September 2009

June 2, 2009
March 29, 2010
April 2009
January 2010   (final data collection date for primary outcome measure)
  • Morning Stiffness Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Nighttime Awakening Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00914290 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Spasticity
  • Multiple Sclerosis
  • Drug: IPX056
    Encapsulated IPX056
    Other Names:
    • IPX056 ER Capsule
    • IPX056 ER
  • Drug: Baclofen
    Encapsulated baclofen capsule
    Other Names:
    • CAS Registry Number [11134-47-0]
    • C10H12ClNO2
  • Experimental: IPX056
    Intervention: Drug: IPX056
  • Active Comparator: Baclofen
    Intervention: Drug: Baclofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
February 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00914290
IPX056-B09-01
No
Impax Pharmaceuticals, a division of Impax Laboratories, Impax Laboratories
IMPAX Laboratories, Inc.
Not Provided
Study Director: Impax Study Director Impax Laboratories (Impax Pharmaceuticals, a division of Impax Laboratories)
IMPAX Laboratories, Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP