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

NCT00914290 | Completed Phase 2 FDA Drug

• 1 other identifier: IPX056-B09-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 11

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).

Conditions

Spasticity; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Morning Stiffness Score

  6 weeks

Study Arms (2)

IPX056-Baclofen IR-IPX056

OTHER

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.

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

IPX056-IPX056-Baclofen IR

ACTIVE COMPARATOR

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.

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

Interventions

IPX056 DRUG

IPX056 ER capsule containing 10 mg baclofen

Also known as: IPX056 ER Capsule, IPX056 ER

IPX056-Baclofen IR-IPX056; IPX056-IPX056-Baclofen IR

Baclofen IR DRUG

Encapsulated baclofen tablet 5 mg per capsule

Also known as: CAS Registry Number [11134-47-0]

IPX056-Baclofen IR-IPX056; IPX056-IPX056-Baclofen IR

Placebo IPX056 DRUG

Placebo capsule for IPX056

IPX056-Baclofen IR-IPX056; IPX056-IPX056-Baclofen IR

Placebo IR DRUG

Placebo encapsulated baclofen placebo tablet

IPX056-Baclofen IR-IPX056; IPX056-IPX056-Baclofen IR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead

Study Sites (11)

Northwest NeuroSpecialists, PLLC

Tucson, Arizona, 85741, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46805, United States

Location

MidAmerica Neuroscience Institute

Lenexa, Kansas, 66214, United States

Location

QUEST Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Great Falls Cllinic

Great Falls, Montana, 59405, United States

Location

Empire Neurology, PC

Latham, New York, 12110, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Impax Study Director

  Impax Laboratories, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: April 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 6, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)