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

Primary Purpose

Spasticity

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Arbaclofen

Placebo

About this trial

This is an interventional treatment trial for Spasticity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arbaclofen Extended-Release

Placebo

Arm Description

Extended-release oral tablet, twice daily dosing (80 mg/day)

Extended-release oral tablet, twice daily dosing

Outcomes

Primary Outcome Measures

Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)

The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The limb with the highest score is the most affected limb. Lower score is better. Scale is from 0 to 5.

Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period

Responder status (AS-MAL-R) consists of three response categorical outcomes based on the Ashworth Scale (AS). Where the possible outcomes are: Strong Responder, Responder, or Non-Responder

Secondary Outcome Measures

Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL)

The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The total of the 4 limbs is the total limbs score. Lower score is better. Scale is from 0 to 5 per joint, Maximum score per limb is 15. Maximum total limbs score is 60.

Clinician's global impression of change (CGIC) for Maintenance Treatment Period

The clinician makes a judgment about the change from baseline of illness severity, the subject's level of distress, other aspects of impairment, and the impact of the illness on functioning. Scale of -3 to +3, higher score is better

Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period

The Numeric Rating Scale of Spasticity is a patient rated measure of the perceived severity of spasticity using a 0-10 numeric rating scale. Lower score is better.

Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period

EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. Scale ranges from 0-10, in 0.5 unit increments. Lower score is better.

Full Information

NCT ID

NCT05179577

First Posted

November 12, 2021

Last Updated

June 2, 2023

Sponsor

RVL Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05179577

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RVL Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

442 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arbaclofen Extended-Release

Arm Type

Active Comparator

Arm Description

Extended-release oral tablet, twice daily dosing (80 mg/day)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Extended-release oral tablet, twice daily dosing

Intervention Type

Drug

Intervention Name(s)

Arbaclofen

Other Intervention Name(s)

OS440, AERT

Intervention Description

Arbaclofen Extended Release Tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets

Primary Outcome Measure Information:

Title

Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)

Description

Time Frame