Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

NCT01359566 | Completed Phase 3

• 1 other identifier: XP-B-089
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 28

Brief Summary

To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)

  numerical score

  10-weeks

• Patient Global Impression of Change (PGIC) score

  numerical score

  10-weeks

Secondary Outcomes (3)

• Change in the overall Modified PRISM score

  Weeks 4, 6, 10

• Change in weekly average severity of pain score associated with muscle spasm.

  Week 10

• Change in weekly average VAS score of sleep quality

  Week 10

Study Arms (4)

Arbaclofen placarbil 15 mg BID

ACTIVE COMPARATOR

Arbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening

Drug: Arbaclofen placarbil 15 mg BID

Arbaclofen placarbil 30 mg BID

ACTIVE COMPARATOR

Arbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening

Drug: Arbaclofen placarbil 30 mg BID

Arbaclofen placarbil 45 mg BID

ACTIVE COMPARATOR

Arbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening

Drug: Arbaclofen placarbil 45 mg BID

Placebo

PLACEBO COMPARATOR

Placebo every morning and every evening

Drug: Placebo

Interventions

Arbaclofen placarbil 15 mg BID DRUG

arbaclofen placarbil 15 mg BID

Also known as: XP19986 SR4

Arbaclofen placarbil 15 mg BID

Placebo DRUG

Placebo for arbaclofen placarbil 15, 30 and 45 mg BID

Also known as: Sugar Pill

Placebo

Arbaclofen placarbil 30 mg BID DRUG

arbaclofen placarbil 30 mg BID

Also known as: XP19986 SR4

Arbaclofen placarbil 30 mg BID

Arbaclofen placarbil 45 mg BID DRUG

arbaclofen placarbil 45 mg BID

Also known as: XP19986 SR4

Arbaclofen placarbil 45 mg BID

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Maximum Ashworth Score Scale score of ≥ 2 in at least one of the following muscle groups on either side of the body: hip abductors/adductors, knee flexors/extensors, ankle flexors/extensors.
• Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.
• If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study.
• Spasticity Disability Rating of 2 or higher at Baseline.
• Willing to discontinue and refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity (including, but not limited to, baclofen, tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid and cannabis).
• Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
• Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
• Subjects who have suffered an acute relapse of MS (as determined by the Investigator) within 90 days prior to Screening, or have had more than 1 relapse within the year prior to Screening
• Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.
• Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
• Subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits
• Gabapentin ≤ 1800 mg per day or pregabalin ≤ 150 mg per day
• Amitriptyline ≤ 75 mg per day or nortriptyline ≤ 75 mg per day
• Opioids ≤ 30 mg morphine equivalents per day.
• Evidence of unstable or severe systemic illness, including but not limited to: Cardiovascular disease (e.g., chronic ventricular arrhythmia, unstable angina or CHF), respiratory disease (e.g., sleep apnea, COPD requiring oxygen therapy or hospitalization in last year), endocrine disease, hepatic disease (e.g., chronic active hepatitis), renal disease, or immunodeficiency.

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (28)

XenoPort Clinical Site

Phoenix, Arizona, 85004, United States

Location

XenoPort Clinical Site

Tucson, Arizona, 85701, United States

Location

XenoPort Clinical Site

Berkeley, California, 94705, United States

Location

XenoPort Clinical Site

San Diego, California, 92103, United States

Location

XenoPort Clinical Site

Denver, Colorado, 80012, United States

Location

XenoPort Clinical Site

Port Charlotte, Florida, 33948, United States

Location

XenoPort Clinical Site

Sarasota, Florida, 34231, United States

Location

XenoPort Clinical Site

St. Petersburg, Florida, 33701, United States

Location

XenoPort Clinical Site

Tampa, Florida, 33604, United States

Location

XenoPort Clinical Site

Lake Barrington, Illinois, 60010, United States

Location

XenoPort Clinical Site

Indianapolis, Indiana, 46204, United States

Location

XenoPort Clinical Site

Lenexa, Kansas, 66210, United States

Location

XenoPort Clinical Site

Lexington, Kentucky, 40505, United States

Location

XenoPort Clinical Site

Bingham Farms, Michigan, 48025, United States

Location

XenoPort Clinical Site

Detroit, Michigan, 48202, United States

Location

XenoPort Clinical Site

Toms River, New Jersey, 08753, United States

Location

XenoPort Clinical Site

Albuquerque, New Mexico, 87102, United States

Location

XenoPort Clinical Site

Albany, New York, 12208, United States

Location

XenoPort Clinical Site

Patchogue, New York, 11772, United States

Location

XenoPort Clinical Site

Plainview, New York, 11803, United States

Location

XenoPort Clinical Site

Asheville, North Carolina, 28805, United States

Location

XenoPort Clinical Site

Akron, Ohio, 44320, United States

Location

XenoPort Clinical Site

Franklin, Tennessee, 37064, United States

Location

XenoPort Clinical Site

Nashville, Tennessee, 37205, United States

Location

XenoPort Clinical Site

San Antonio, Texas, 78206, United States

Location

XenoPort Clinical Site

Vienna, Virginia, 22181, United States

Location

XenoPort Clinical Site

Seattle, Washington, 98108, United States

Location

XenoPort Clinical Site

Tacoma, Washington, 98404, United States

Location

Related Links

• The Command Clinical Research Trial Website

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

arbaclofen placarbil; BID protein, human; Sugars

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Study Director

  Indivior Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2011
• First Posted: May 24, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)