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A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis - NCT00914290-12110(Clinical Trial 296628)



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City:  Latham
State:  
NY
Zip Code: 12110
Conditions: Spasticity - Multiple Sclerosis
Purpose: To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).
Study summary:
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.
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Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
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