Trial · NCT03290131

A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS

NCT03290131, Phase 3, Completed, RVL Pharmaceuticals, Inc.; results first posted 2022-07-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS. Trials, record NCT03290131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03290131

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS
NCT number: NCT03290131
Status: Completed
Phases: Phase 3
Enrollment: 536 participants, actual
Lead sponsor: RVL Pharmaceuticals, Inc.
Conditions: Multiple Sclerosis, Spasticity, Muscle
Interventions: Arbaclofen, Placebo
First posted: 2017-09-21
Last updated: 2022-07-15
Results first posted: 2022-07-15

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)	84 days	Total Numeric-Transformed Modified Ashworth Scale (TNmAS) is a 6-point scale to measure abnormality in tone or the resistance to passive movements. Higher score is worse outcome. For each joint, the minimum score is 0; maximum score is 5. The values for each of the 3 main joints are summed for the limb score. The limb with the highest score is the most affected limb (MAL). The highest possible score for a limb is 15. Limb range: 0 to 15. To arrive at total limbs (TL) score the values for all 4 limbs are summed; maximum total limb score is 60. TL range: 0 to 60.
Primary	Clinical Global Impression of Change (CGIC)	84 days	The Clinical Global Impression of Change (CGIC) was developed to provide a brief, stand-alone assessment of the clinician's view of the subject's global functioning prior to and after initiating a study medication. The scale ranges from -3 to +3 judging whether the change is significantly worse (-3) to significantly improved (+3). Higher score is better outcome. The CGIC scale will be used to measure the overall change in the subject's condition since starting the study. There is no baseline value because the score is a measure of how the patient changed from baseline (treatment initiation).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)	84 days		units on a scale	MEAN
PRIMARY	Clinical Global Impression of Change (CGIC)	84 days		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)	AERT 40 mg	-1.7	Standard Deviation 1.97	units on a scale
Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)	AERT 80 mg	-2.0	Standard Deviation 1.78	units on a scale
Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)	Placebo	-1.4	Standard Deviation 1.82	units on a scale
Clinical Global Impression of Change (CGIC)	AERT 40 mg	0.6	Standard Deviation 1.0	units on a scale
Clinical Global Impression of Change (CGIC)	AERT 80 mg	0.4	Standard Deviation 1.23	units on a scale
Clinical Global Impression of Change (CGIC)	Placebo	0.6	Standard Deviation 0.94	units on a scale

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AERT 40 mg	179
Overall Study	STARTED	AERT 80 mg	179
Overall Study	STARTED	Placebo	178
Overall Study	COMPLETED	AERT 40 mg	137
Overall Study	COMPLETED	AERT 80 mg	107
Overall Study	COMPLETED	Placebo	159
Overall Study	NOT COMPLETED	AERT 40 mg	42
Overall Study	NOT COMPLETED	AERT 80 mg	72
Overall Study	NOT COMPLETED	Placebo	19

Source ClinicalTrials.gov

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Urinary Tract Disorder	Renal and urinary disorders	AERT 40 mg	56	179	56
other	Urinary Tract Disorder	Renal and urinary disorders	AERT 80 mg	57	179	57
other	Urinary Tract Disorder	Renal and urinary disorders	Placebo	67	178	67
other	Muscular Weakness	Musculoskeletal and connective tissue disorders	AERT 40 mg	43	179	43
other	Muscular Weakness	Musculoskeletal and connective tissue disorders	AERT 80 mg	40	179	40
other	Muscular Weakness	Musculoskeletal and connective tissue disorders	Placebo	27	178	27
other	Asthenia	General disorders	AERT 40 mg	24	179	24
other	Asthenia	General disorders	AERT 80 mg	37	179	37
other	Asthenia	General disorders	Placebo	27	178	27
other	Dizziness	Nervous system disorders	AERT 40 mg	27	179	27

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AERT 40 mg	0	179
Total, all-cause mortality	AERT 80 mg	0	179
Total, all-cause mortality	Placebo	0	178
Total, other adverse events	AERT 40 mg	148	179
Total, other adverse events	AERT 80 mg	154	179
Total, other adverse events	Placebo	133	178
Total, serious adverse events	AERT 40 mg	7	179
Total, serious adverse events	AERT 80 mg	6	179
Total, serious adverse events	Placebo	6	178

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03290131

GET https://conductscience.org/api/trials/v1/NCT03290131/events?page=2

API reference For AI assistants