Trial record 2 of 4 for:    MS and arbaclofen

Arbaclofen Placarbil for the Treatment of Spasticity in Subjects With Multiple Sclerosis (MS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT01360489
First received: May 23, 2011
Last updated: July 14, 2014
Last verified: April 2013
  Purpose

This is an open-label, 26-week safety and efficacy study in subjects with spasticity due to MS who have completed the XP-B-089 Study, and also includes an addendum open-label, 36-week safety study in subjects with spasticity due to MS who have not participated in the XP-B-089 study to assess the long-term safety and efficacy of arbaclofen placarbil in subjects with spasticity due to MS.


Condition Intervention Phase
Multiple Sclerosis
Drug: arbaclofen placarbil
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, 26-Week Study Assessing Arbaclofen Placarbil Safety and Efficacy in Subjects With Spasticity Associated With Multiple Sclerosis With an Addendum Open-Label, 36-Week Study Assessing Arbaclofen Placarbil Safety in Subjects With Spasticity Associated With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, severe TEAEs, related TEAEs, TEAEs leading to early withdrawal, TEAEs during taper, and TEAEs due to abrupt discontinuation. [ Time Frame: 26 and 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in maximum Ashworth score through the end of treatment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: September 2011
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 45 mg BID
arbaclofen placarbil
Drug: arbaclofen placarbil
This is an open-label study during which all subjects will be initiated and maintained on 45 mg BID of arbaclofen placarbil therapy for 26 or 36 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Primary Study Inclusion:

  1. Subjects who have successfully completed study XP-B-089.
  2. If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must have remained stable for the duration of study XP-B-089.
  3. Willing to continue to 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 (refer to Appendix 2, Prohibited Concomitant Medications).

Primary Study Exclusion:

  1. Scheduled elective surgery or other procedures requiring general anesthesia during the study.
  2. Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.
  3. Subjects who have an unstable or clinically significant medical or psychiatric illness that, in the opinion of the Investigator, could confound the collection of meaningful safety data or pose a risk to the subject.
  4. Treatment with botulinum toxin products, phenol, or alcohol injections during or subsequent to the previous study XP-B-089, or plans to receive these treatments during the time period of study XP-B-091

Addendum Study Inclusion:

  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. Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive
  3. Spasticity Disability Rating of 2 or higher at Screening
  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. 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).

Addendum Study Exclusion:

  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. Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
  5. At the start, 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.
  6. Botulinum toxin, phenol, or alcohol injections within 6 months of screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360489

  Show 28 Study Locations
Sponsors and Collaborators
XenoPort, Inc.
  More Information

No publications provided

Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT01360489     History of Changes
Other Study ID Numbers: XP-B-091
Study First Received: May 23, 2011
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arbaclofen placarbil
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Baclofen
Central Nervous System Agents
GABA Agents
GABA Agonists
GABA-B Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014