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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IMPAX Laboratories, Inc.; Impax Laboratories, LLC
• Treatments: Baclofen

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.