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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914290
• Other study ID #: IPX056-B09-01
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2017
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis
• Spasticity

Intervention

Drug:
• IPX056
IPX056 ER capsule containing 10 mg baclofen
• Baclofen IR
Encapsulated baclofen tablet 5 mg per capsule
• Placebo IPX056
Placebo capsule for IPX056
• Placebo IR
Placebo encapsulated baclofen placebo tablet

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning Stiffness Score		6 weeks