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

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:

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
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:

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
Subjects with back spasm related to major trauma to the region
Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation
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

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
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013