Clinical trial NCT00914290: A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
Official title: A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spasticity
Multiple Sclerosis
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Morning Stiffness Score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, PLLC
state: Arizona
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Bingham Farms
country: United States
facility: QUEST Research Institute
state: Michigan
city: Great Falls
country: United States
facility: Great Falls Cllinic
state: Montana
city: Latham
country: United States
facility: Empire Neurology, PC
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References: