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

Multiple Sclerosis Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359566
• Other study ID #: XP-B-089
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2021
• Source: XenoPort, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Other known NCT identifiers

• NCT01360489

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Arbaclofen placarbil 15 mg BID
arbaclofen placarbil 15 mg BID
• Placebo
Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
• Arbaclofen placarbil 30 mg BID
arbaclofen placarbil 30 mg BID
• Arbaclofen placarbil 45 mg BID
arbaclofen placarbil 45 mg BID

Locations

Country	Name	City	State
United States	XenoPort Clinical Site	Akron	Ohio
United States	XenoPort Clinical Site	Albany	New York
United States	XenoPort Clinical Site	Albuquerque	New Mexico
United States	XenoPort Clinical Site	Asheville	North Carolina
United States	XenoPort Clinical Site	Berkeley	California
United States	XenoPort Clinical Site	Bingham Farms	Michigan
United States	XenoPort Clinical Site	Denver	Colorado
United States	XenoPort Clinical Site	Detroit	Michigan
United States	XenoPort Clinical Site	Franklin	Tennessee
United States	XenoPort Clinical Site	Indianapolis	Indiana
United States	XenoPort Clinical Site	Lake Barrington	Illinois
United States	XenoPort Clinical Site	Lenexa	Kansas
United States	XenoPort Clinical Site	Lexington	Kentucky
United States	XenoPort Clinical Site	Nashville	Tennessee
United States	XenoPort Clinical Site	Patchogue	New York
United States	XenoPort Clinical Site	Phoenix	Arizona
United States	XenoPort Clinical Site	Plainview	New York
United States	XenoPort Clinical Site	Port Charlotte	Florida
United States	XenoPort Clinical Site	Saint Petersburg	Florida
United States	XenoPort Clinical Site	San Antonio	Texas
United States	XenoPort Clinical Site	San Diego	California
United States	XenoPort Clinical Site	Sarasota	Florida
United States	XenoPort Clinical Site	Seattle	Washington
United States	XenoPort Clinical Site	Tacoma	Washington
United States	XenoPort Clinical Site	Tampa	Florida
United States	XenoPort Clinical Site	Toms River	New Jersey
United States	XenoPort Clinical Site	Tucson	Arizona
United States	XenoPort Clinical Site	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
XenoPort, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)	numerical score	10-weeks
Primary	Patient Global Impression of Change (PGIC) score	numerical score	10-weeks
Secondary	Change in the overall Modified PRISM score	Variables	Weeks 4, 6, 10
Secondary	Change in weekly average severity of pain score associated with muscle spasm.	numerical score	Week 10
Secondary	Change in weekly average VAS score of sleep quality	numerical score	Week 10

External Links

•   The Command Clinical Research Trial Website