IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

NCT00488839 | Completed Phase 3

• 2 other identifiers: IPX056-B06-032007-000236-16
• Study Type: interventional
• Target: 173
• Locations: 5 countries
• Sites: 31

Brief Summary

The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine how long IPX056 affects spasticity.

Conditions

Multiple Sclerosis

Keywords

Spasticity; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Overall mean changes from predose (baseline) in total Ashworth scores of the four lower extremity muscle groups (hip adductors, knee flexors, knee extensors, and plantar flexors) of both lower limbs over 12 hours assessed hourly after dosing

  12 hours

Secondary Outcomes (2)

• Duration of effect (improvement in Ashworth Scale) for IPX056

  12 hours

• Establishment of relationships between baclofen plasma concentration with improvement in Ashworth Scale

  12 hours

Study Arms (4)

IPX056 20 mg - OLE

OTHER

A single dose of IPX056 20 mg, Placebo IPX056 40 mg and Placebo Baclofen Tablet (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg)

Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: Placebo Baclofen Tablet; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 40 mg

IPX056 40 mg - OLE

OTHER

A single dose of IPX056 40 mg, Placebo IPX056 20 mg and Placebo Baclofen Tablet (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg)

Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: Placebo Baclofen Tablet; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 20 mg

Baclofen 20 mg - OLE

OTHER

A single dose of Encapsulated Baclofen 20 mg, Placebo IPX056 20 mg and Placebo IPX056 40 mg (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg)

Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 20 mg; Drug: Placebo IPX056 40 mg

Placebo - OLE

OTHER

A single dose of Placebo Baclofen Tablet, Placebo IPX056 20 mg and Placebo IPX056 40 mg (Part 1), 9 week Open label extension of IPX056 (flexible dose design,IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg)

Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: Placebo Baclofen Tablet; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 20 mg; Drug: Placebo IPX056 40 mg

Interventions

IPX056 20 mg DRUG

IPX056 Extended Release capsule containing 20 mg baclofen

Also known as: Baclofen ER 20 mg

Baclofen 20 mg - OLE; IPX056 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

IPX056 40 mg DRUG

IPX056 Extended Release capsule containing 40 mg baclofen

Also known as: Baclofen ER 40 mg

Baclofen 20 mg - OLE; IPX056 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

Encapsulated Baclofen 20 mg DRUG

Baclofen 20mg tablet was encapsulated for blinding.

Also known as: Active comparator

Baclofen 20 mg - OLE; IPX056 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

Placebo Baclofen Tablet DRUG

Placebo capsule encapsulated placebo Baclofen tablet

IPX056 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

IPX056 10 mg DRUG

IPX056 Extended Release capsule containing 10 mg baclofen

Also known as: Baclofen ER 10 mg

Baclofen 20 mg - OLE; IPX056 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

IPX056 30 mg DRUG

IPX056 Extended Release capsule containing 30 mg baclofen

Also known as: Baclofen ER 30 mg

Baclofen 20 mg - OLE; IPX056 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

IPX056 35 mg DRUG

IPX056 Extended Release capsule containing 35 mg baclofen

Also known as: Baclofen ER 35 mg

Baclofen 20 mg - OLE; IPX056 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

Placebo IPX056 20 mg DRUG

Placebo capsule for IPX056 20 mg

Baclofen 20 mg - OLE; IPX056 40 mg - OLE; Placebo - OLE

Placebo IPX056 40 mg DRUG

Placebo capsule for IPX056 40 mg

Baclofen 20 mg - OLE; IPX056 20 mg - OLE; Placebo - OLE

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. If female and of childbearing potential, continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as oral, injected, or implanted contraceptives, or barrier contraception). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study. Female subjects of childbearing potential must have a negative urine pregnancy test immediately prior to study entry.
• Able to understand and willing to voluntarily sign an informed consent form (ICF) and an Authorization to Use and Disclose Protected Health Information form (as required by the Health Insurance Portability and Accountability Act {HIPAA} legislation, if appropriate for the region) prior to the performance of any study-specific procedures.
• Has a negative urine drug screen at screening visit.
• Has Definite multiple sclerosis by Poser or McDonald Criteria.
• Expanded Disability Status Scale (EDSS) rating between 3.0-8.0
• Has a normal ECG and a blood pressure \<160/95 mmHg (systolic)/diastolic) at screening, measured in the sitting position after approximately 5 minutes of quiet rest.
• If the subject has a history of or presence of clinically significant peptic ulcers, liver disease, diabetes mellitus, hypertension or heart disease, the subject must be on a stable treatment regimen for a minimum of 3 months prior to Screening Visit
• Wiling to wash out current medication with anti-spasticity activities, including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and tizanidine.
• Ashworth score of 2 or more for at least one of the three lower extremity muscle groups (hip adductor, knee flexor, knee extensor) in the most affected limb and a total minimum score of 6 for four muscle groups (the above three plus plantar flexor) on both limbs (maximum total score is 32) during screening visit and at pre-dose during PK/PD Visit 1.
• Able and willing to comply with the protocol, including availability for all scheduled clinic visits

You may not qualify if:

• If female, the subject is:
• pregnant; or planning to become pregnant; or
• breastfeeding; or
• a woman of child-bearing potential (defined as post menarche and biologically capable of becoming pregnant \[i.e., not surgically sterile\]) who is engaged in active heterosexual relations and is not using a barrier or hormonal form of birth control (i.e. oral, injected, or implanted contraceptives).
• History of allergic or severe intolerance to baclofen.
• Did not respond to previous baclofen treatment in any formulation.
• Treated with intrathecal baclofen within the previous 6 months prior to the Screening Visit.
• Has experienced an exacerbation of MS within 6 months prior to the Screening Visit.
• Symptomatic urinary tract infection (UTI) within 4 weeks prior to the Screening Visit and more than two (2) UTI incidents within the last 6 months.
• Serum creatinine level ≥ 2 x ULN (upper limit of normal reference range) at the Screening Visit or requires dialysis.
• Liver enzyme values ≥ 2 x ULN (upper limit of normal reference range) at the Screening Visit.
• Uncontrolled peptic ulcers, liver disease, diabetes mellitus, bladder sphincter hypertonia, hypertension or heart disease.
• History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment or control of seizure.
• Concomitant neurologic conditions causing spasticity (e.g. stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g. Parkinson's disease).
• Any medical condition, including psychiatric disease, which would interfere with the interpretation of the study results, the conduct of the study, or the safety of the subject.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead

Study Sites (31)

Northwest NeuroSpecialists

Tucson, Arizona, 85741, United States

Location

OrthoArkansas, P. A.

Little Rock, Arkansas, 72201, United States

Location

OrthoArkansas, P.A.

Little Rock, Arkansas, 72201, United States

Location

Patricia Fodor

Colorado Springs, Colorado, 80919, United States

Location

Sunrise Clinical Research

Hollywood, Florida, 33021, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

MS Center of Atlanta

Atlanta, Georgia, 30327, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Elkhardt Clinic

Elkhart, Indiana, 46514, United States

Location

MidAmerica Neuroscience Institute

Lenexa, Kansas, 66214, United States

Location

Springfield Neurology

Springfield, Massachusetts, 01104, United States

Location

General Clinical Research Center 7A

Ann Arbor, Michigan, 48109, United States

Location

Medex Healthcare Research, Inc.

Saint Louis, Michigan, 63117, United States

Location

Northern Michigan Neurology

Traverse City, Michigan, 49684, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Crozer Chester Medical Center

Upland, Pennsylvania, 19013, United States

Location

Bhupesh Dihenia

Lubbock, Texas, 79410, United States

Location

Integra Clinical Research

San Antonio, Texas, 78229, United States

Location

Neurological Research Center

Bennington, Vermont, 05201, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Foothills Medical Centre, MS Clinic, SSB

Calgary, t2n 2t9, Canada

Location

West-Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

Vecmilgravis Hospital, Latvian Maritime Medicine Center

Riga, Latvia

Location

Chernihiv Regional Hospital Department of Neurology

Chernihiv, 14029, Ukraine

Location

Neurology and Neurosurgery Dpt., Postgraduation training faculty, Dnipropetrovsk State medical Academy

Dnipropetrovsk, 49027, Ukraine

Location

Institue of Neruology, Psychiatry and Narcology of AMS of Ukraine

Kharkiv, 61068, Ukraine

Location

Department of nervous system demyelization diseases of City Clinical Hospital

Kyiv, 03110, Ukraine

Location

Odessa Regional Clinical Hospital

Odesa, 65025, Ukraine

Location

Neurology department of Ukraine medical stomatological akademy

Poltava, 36024, Ukraine

Location

Vinnytsya Regional Psychoneurological Hospital

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Officials

• Impax Study Director

  Impax Laboratories, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 6, 2019

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1); US (20); CA (2); UA (7); ES (1)