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

Impax Laboratories

Status and phase: Completed; Phase 2

Conditions: Spasticity; Multiple Sclerosis

Treatments: Drug: Placebo IPX056; Drug: Baclofen IR; Drug: IPX056; Drug: Placebo IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914290

IPX056-B09-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

IPX056-Baclofen IR-IPX056

Other group

Description:

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.

Treatment:

Drug: IPX056

Drug: Placebo IR

Drug: Placebo IPX056

Drug: Baclofen IR

IPX056-IPX056-Baclofen IR

Active Comparator group

Description:

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.

Treatment:

Drug: IPX056

Drug: Placebo IR

Drug: Placebo IPX056

Drug: Baclofen IR