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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01359566

Enrollment

228

Registered

2011-05-24

Start date

2011-05-31

Completion date

2013-02-28

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief 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).

Interventions

DRUGArbaclofen placarbil 15 mg BID

arbaclofen placarbil 15 mg BID

DRUGPlacebo

Placebo for arbaclofen placarbil 15, 30 and 45 mg BID

DRUGArbaclofen placarbil 30 mg BID

arbaclofen placarbil 30 mg BID

DRUGArbaclofen placarbil 45 mg BID

arbaclofen placarbil 45 mg BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)	10-weeks	numerical score
Patient Global Impression of Change (PGIC) score	10-weeks	numerical score

Secondary

Measure	Time frame	Description
Change in the overall Modified PRISM score	Weeks 4, 6, 10	Variables
Change in weekly average severity of pain score associated with muscle spasm.	Week 10	numerical score
Change in weekly average VAS score of sleep quality	Week 10	numerical score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026