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A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00817986
First received: January 6, 2009
Last updated: September 14, 2010
Last verified: September 2010
  Purpose

The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.


Condition Intervention Phase
Back Spasms
Drug: Arbaclofen placarbil, 20 mg BID
Drug: Placebo
Drug: Arbaclofen placarbil, 30 mg BID
Drug: Arbaclofen placarbil, 40 mg BID
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms

Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs


Secondary Outcome Measures:
  • Change in pain severity score using the VAS [ Time Frame: 4 Days ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: Arbaclofen placarbil, 20 mg BID
After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
Experimental: Cohort 2 Drug: Arbaclofen placarbil, 30 mg BID
After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
Experimental: Cohort 3 Drug: Arbaclofen placarbil, 40 mg BID
After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
Experimental: Cohort 4 Drug: Placebo
After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute moderate to severe muscle spasms in the lumbar region, as indicated by a minimum Visual Analog Scale pain severity score of 4.0 cm, beginning either:

    • within four days prior to screening for subjects who do not require a 24-hour washout

    Or

    • within three days for subjects who require a 24-hour washout
  2. Willing to discontinue all analgesics (e.g. NSAIDS, COX-2 inhibitors, acetaminophen), aspirin >81 mg/day, short-acting muscle relaxants (i.e. carisoprodol, Soma®), and herbal remedies for pain at least 24 hours prior to first dose and to refrain from use during the study (cardio-protective doses of aspirin ≤ 81 mg /day are allowed).

Exclusion Criteria:

  1. Clinically significant abnormal neurological history or examination at screening (excluding back spasm), including lumbar radicular symptoms, spinal stenosis, foot drop, herniated nucleus pulposus, or other structural defects
  2. Subjects with back spasm related to major trauma to the region
  3. Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation
  4. Subjects using any of the following medications at screening:

    • Opioids, both short- and long-acting including but not limited to: morphine, fentanyl patch, oxycodone, tramadol)
    • benzodiazepines, such as valium and lorazepam
    • cyclobenzaprine containing drugs (e.g., Flexeril, Amrix)
    • carisoprodol (e.g., Soma®) within 24 hours 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: NCT00817986

Locations
United States, Arizona
Litchfield Park, Arizona, United States, 85340
United States, California
Anaheim, California, United States, 92084
Anaheim, California, United States, 92801
San Diego, California, United States, 92128
Vista, California, United States, 92083
United States, Florida
Fort Lauderdale, Florida, United States, 33306
Miami, Florida, United States, 33143
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Kansas
Overland Park, Kansas, United States, 66211
United States, Kentucky
Erlanger, Kentucky, United States, 41018
United States, Michigan
Traverse City, Michigan, United States, 49684
United States, New Jersey
Brick, New Jersey, United States, 07732
United States, North Carolina
Raleigh, North Carolina, United States, 27612
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73122
United States, South Carolina
Anderson, South Carolina, United States, 29621
United States, Texas
Dallas, Texas, United States, 75234
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78215
United States, Utah
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
XenoPort, Inc.
  More Information

No publications provided

Responsible Party: Jay Huff, M.D., Vice President Clinical Development, XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT00817986     History of Changes
Other Study ID Numbers: XP-B-083
Study First Received: January 6, 2009
Last Updated: September 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by XenoPort, Inc.:
Acute back spasms in the lumbar region

Additional relevant MeSH terms:
Spasm
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Arbaclofen placarbil
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 November 24, 2014