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

Condition(s) targeted: Spasticity; Multiple Sclerosis

Intervention: IPX056 (Drug); Baclofen (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: IMPAX Laboratories, Inc.

Official(s) and/or principal investigator(s):
Impax Study Director, Study Director, Affiliation: Impax Laboratories (Impax Pharmaceuticals, a division of Impax Laboratories)

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

Official title: A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

Morning Stiffness Score

Nighttime Awakening Score

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Northwest NeuroSpecialists, PLLC, Tucson, Arizona 85741, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 520-742-1833

University of Colorado, Aurora, Colorado 80045, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 303-724-2198

Meridien Research, Tampa, Florida 33606, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 813-877-8839

Fort Wayne Neurological Center, Fort Wayne, Indiana 46805, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 260-460-3257

MidAmerica Neuroscience Institute, Lenexa, Kansas 66214, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 913-894-1500, Ext: 166

QUEST Research Institute, Bingham Farms, Michigan 48025, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 248-644-7770

Great Falls Cllinic, Great Falls, Montana 59405, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 406-268-3923

Empire Neurology, PC, Latham, New York 12110, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 802-447-7577

Winthrop University Hospital, Mineola, New York 11501, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 516-663-9582

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 336-716-1704

Central Texas Neurology Consultants, Round Rock, Texas 78681, United States; Recruiting
IPX056-B09-01 Study Coordinator, Phone: 512-218-1222

Starting date: April 2009
Ending date: November 2009
Last updated: September 21, 2009