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

Completed · Phase 2 · Has a placebo group

Conditions studied: Spasticity, Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT00914290

Run by

Impax Laboratories, LLC

People needed

23

Starts

2009-04-01

Expected to finish

2010-02-01

Last updated by the study team

2019-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwest NeuroSpecialists, PLLC — Tucson, Arizona, United States
• University of Colorado — Aurora, Colorado, United States
• Meridien Research — Tampa, Florida, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• MidAmerica Neuroscience Institute — Lenexa, Kansas, United States
• QUEST Research Institute — Bingham Farms, Michigan, United States
• Great Falls Cllinic — Great Falls, Montana, United States
• Empire Neurology, PC — Latham, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Central Texas Neurology Consultants — Round Rock, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.