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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01359566
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2011
First Posted Date  ICMJE May 24, 2011
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
  • Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point) [ Time Frame: 10-weeks ]
  • Patient Global Impression of Change (PGIC) score [ Time Frame: 10-weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
  • Change in the overall Modified PRISM score [ Time Frame: Weeks 4, 6, 10 ]
  • Change in weekly average severity of pain score associated with muscle spasm. [ Time Frame: Week 10 ]
  • Change in weekly average VAS score of sleep quality [ Time Frame: Week 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
Official Title  ICMJE A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Arbaclofen placarbil 15 mg BID
    arbaclofen placarbil 15 mg BID
    Other Name: XP19986 SR4
  • Drug: Placebo
    Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
    Other Name: Sugar Pill
  • Drug: Arbaclofen placarbil 30 mg BID
    arbaclofen placarbil 30 mg BID
    Other Name: XP19986 SR4
  • Drug: Arbaclofen placarbil 45 mg BID
    arbaclofen placarbil 45 mg BID
    Other Name: XP19986 SR4
Study Arms  ICMJE
  • Active Comparator: Arbaclofen placarbil 15 mg BID
    Arbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening
    Intervention: Drug: Arbaclofen placarbil 15 mg BID
  • Active Comparator: Arbaclofen placarbil 30 mg BID
    Arbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening
    Intervention: Drug: Arbaclofen placarbil 30 mg BID
  • Active Comparator: Arbaclofen placarbil 45 mg BID
    Arbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening
    Intervention: Drug: Arbaclofen placarbil 45 mg BID
  • Placebo Comparator: Placebo
    Placebo every morning and every evening
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2013)
228
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2011)
200
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Has multiple sclerosis (MS) based on Poser or McDonald Criteria (all subtypes of MS will be accepted, including relapsing remitting, primary or secondary progressive, if disease is stable per exclusion criteria).
  2. 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.
  3. Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.
  4. 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.
  5. Spasticity Disability Rating of 2 or higher at Baseline.
  6. 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).

Exclusion Criteria:

  1. Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
  2. Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
  3. 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
  4. Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.
  5. Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
  6. 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.
  7. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01359566
Other Study ID Numbers  ICMJE XP-B-089
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Indivior Inc.
Study Sponsor  ICMJE Indivior Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Indivior Inc.
PRS Account Indivior Inc.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP