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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT01359566
• Date of registration: 22/05/2011
• Prospective Registration: No
• Primary sponsor: XenoPort, Inc.
• Public title: Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
• Scientific title: A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
• Date of first enrolment: May 2011
• Target sample size: 228
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01359566
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Study Director
• Affiliation: Indivior Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Arbaclofen placarbil 45 mg BID

Drug: Placebo

Drug: Arbaclofen placarbil 15 mg BID

Drug: Arbaclofen placarbil 30 mg BID

Primary Outcome(s)

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]

Secondary Outcome(s)

Change in weekly average VAS score of sleep quality [Time Frame: Week 10]

Change in weekly average severity of pain score associated with muscle spasm. [Time Frame: Week 10]

Change in the overall Modified PRISM score [Time Frame: Weeks 4, 6, 10]

Secondary ID(s)

XP-B-089

Source(s) of Monetary Support

Please refer to primary and secondary sponsors