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

Phase 2

Completed

• Conditions: Spasticity; Multiple Sclerosis
• Interventions: Drug: IPX056; Drug: Baclofen IR; Drug: Placebo IPX056; Drug: Placebo IR

• Registration Number: NCT00914290
• Lead Sponsor: Impax Laboratories, LLC

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 effect.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Disposition First Submitted: 2013-09-27
• Disposition First Submitted QC: 2015-09-08
• Disposition First Posted: 2015-09-22
• Status Verified: 2017-05
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IPX056-Baclofen IR-IPX056	IPX056	Following 2 weeks of run-in period, subjects were randomized to IPX056 and Placebo IR for 2 weeks and then to Baclofen IR and Placebo IPX056 for 2 weeks.
IPX056-IPX056-Baclofen IR	Baclofen IR	Following 2 weeks of run-in period, subjects were randomized to Baclofen IR and Placebo IPX056 for 2 weeks and then to IPX056 and Placebo IR for 2 weeks.
IPX056-IPX056-Baclofen IR	Placebo IPX056	Following 2 weeks of run-in period, subjects were randomized to Baclofen IR and Placebo IPX056 for 2 weeks and then to IPX056 and Placebo IR for 2 weeks.
IPX056-Baclofen IR-IPX056	Placebo IR	Following 2 weeks of run-in period, subjects were randomized to IPX056 and Placebo IR for 2 weeks and then to Baclofen IR and Placebo IPX056 for 2 weeks.
IPX056-Baclofen IR-IPX056	Baclofen IR	Following 2 weeks of run-in period, subjects were randomized to IPX056 and Placebo IR for 2 weeks and then to Baclofen IR and Placebo IPX056 for 2 weeks.
IPX056-Baclofen IR-IPX056	Placebo IPX056	Following 2 weeks of run-in period, subjects were randomized to IPX056 and Placebo IR for 2 weeks and then to Baclofen IR and Placebo IPX056 for 2 weeks.
IPX056-IPX056-Baclofen IR	IPX056	Following 2 weeks of run-in period, subjects were randomized to Baclofen IR and Placebo IPX056 for 2 weeks and then to IPX056 and Placebo IR for 2 weeks.
IPX056-IPX056-Baclofen IR	Placebo IR	Following 2 weeks of run-in period, subjects were randomized to Baclofen IR and Placebo IPX056 for 2 weeks and then to IPX056 and Placebo IR for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Morning Stiffness Score	6 weeks

Trial Locations

Locations (11)

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

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