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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: May 5, 2017
Last verified: May 2017
June 2, 2009
May 5, 2017
April 2009
January 2010   (Final data collection date for primary outcome measure)
Morning Stiffness Score [ Time Frame: 6 weeks ]
  • Morning Stiffness Score [ Time Frame: 6 weeks ]
  • Nighttime Awakening Score [ Time Frame: 6 weeks ]
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).
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
  • Spasticity
  • Multiple Sclerosis
  • 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
  • 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.
    Interventions:
    • Drug: IPX056
    • Drug: Baclofen IR
    • Drug: Placebo IPX056
    • Drug: Placebo IR
  • 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.
    Interventions:
    • Drug: IPX056
    • Drug: Baclofen IR
    • Drug: Placebo IPX056
    • Drug: Placebo IR
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00914290
IPX056-B09-01
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Not Provided
Study Director: Impax Study Director Impax Laboratories (Impax Pharmaceuticals, a division of Impax Laboratories)
IMPAX Laboratories, Inc.
May 2017

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