Status:
COMPLETED
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Spasticity
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00914290
Start Date
April 1 2009
End Date
February 1 2010
Last Update
November 6 2019
Active Locations (11)
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1
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States, 85741
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Meridien Research
Tampa, Florida, United States, 33606
4
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46805