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Not yet recruiting NCT05179577

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Phase III Interventional Spasticity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arbaclofen, Placebo.
Who it may be relevant to
Registry conditions: Spasticity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)

Overview

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets (80 mg/day) in MS patients with spasticity. Arbaclofen ER will be compared with placebo. The treatment groups will be randomized in a 1:1 ratio. There will be a 49-day dose escalation period, followed by a 84-day maintenance treatment period, followed by a 21-day taper period.

Interventions

  • Drug Arbaclofen
    Arbaclofen Extended Release Tablets
  • Drug Placebo
    Placebo tablets

Primary outcome measures

  • Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL) [Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period [Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
Secondary outcome measures (4)
  • Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL) [Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Clinician's global impression of change (CGIC) for Maintenance Treatment Period [Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period [Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period [Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]

Eligibility criteria

Inclusion criteria

  • Subjects 18 to 65 years of age, inclusive
  • An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
  • Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
  • Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
  • Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement
  • Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects)
  • Willing to sign the informed consent form (ICF)

Exclusion criteria

  • Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
  • In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
  • Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
  • Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
  • Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
  • Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma
  • Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05179577 · OS440-3006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗