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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Spasticity Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IPX056-Baclofen IR-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.

Group Type OTHER

IPX056

Intervention Type DRUG

IPX056 ER capsule containing 10 mg baclofen

Baclofen IR

Intervention Type DRUG

Encapsulated baclofen tablet 5 mg per capsule

Placebo IPX056

Intervention Type DRUG

Placebo capsule for IPX056

Placebo IR

Intervention Type DRUG

Placebo encapsulated baclofen placebo tablet

IPX056-IPX056-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.

Group Type ACTIVE_COMPARATOR

IPX056

Intervention Type DRUG

IPX056 ER capsule containing 10 mg baclofen

Baclofen IR

Intervention Type DRUG

Encapsulated baclofen tablet 5 mg per capsule

Placebo IPX056

Intervention Type DRUG

Placebo capsule for IPX056

Placebo IR

Intervention Type DRUG

Placebo encapsulated baclofen placebo tablet

Interventions

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IPX056

IPX056 ER capsule containing 10 mg baclofen

Intervention Type DRUG

Baclofen IR

Encapsulated baclofen tablet 5 mg per capsule

Intervention Type DRUG

Placebo IPX056

Placebo capsule for IPX056

Intervention Type DRUG

Placebo IR

Placebo encapsulated baclofen placebo tablet

Intervention Type DRUG

Other Intervention Names

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IPX056 ER Capsule IPX056 ER CAS Registry Number [11134-47-0]

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No