Trial · NCT03319732

A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS

NCT03319732, 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 Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS. Trials, record NCT03319732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03319732

On this page

Trial

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

Title: A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS
NCT number: NCT03319732
Status: Completed
Phases: Phase 3
Enrollment: 323 participants, actual
Lead sponsor: RVL Pharmaceuticals, Inc.
Conditions: Multiple Sclerosis, Spasticity, Muscle
Interventions: Arbaclofen
First posted: 2017-10-24
Last updated: 2022-08-09
Results first posted: 2022-07-15

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events, Change in Vital Signs, Clinical Laboratory Test Results, 12-lead ECGs, USP Questionnaire, and C-SSRS Results	over 1 year	Safety and tolerability will be assessed by the monitoring of adverse events volunteered, observed, and elicited by general questions in a non-suggestive manner. Changes in vital signs, clinical laboratory test results, 12-lead ECGs, the urinary symptom profile (USP) questionnaire, and the C-SSRS results will also be assessed.
Secondary	Patient Global Impression of Change (PGIC)	week 60	Patient Global impression of Change (PGIC) is a scale to evaluate the change in activity limitations, symptoms, emotions, and overall quality of life using scores from 1 to 7 with 1 being no change and 7 being a great deal better, and a considerable improvement that has made all the difference. Minimum value is 1 and the maximum value is 7.
Secondary	Total Numeric-transformed Modified Ashworth Scale Score or the Most Affected Limb (TNmAS-MAL)	week 28	The abbreviated scale title is TNmAS. It is considered the primary clinical measure of muscle spasticity in subjects with neurological conditions. It is a useful 6-point rating scale (0 to 5) to measure abnormality in tone or the resistance to passive movements. Minimum value is 0 and maximum value is 5. A higher score means a worse outcome.
Secondary	Expanded Disability Status Scale (EDSS)	week 60	Expanded Disability Status Scale (EDSS) is a method of quantifying disability in MS and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5-unit increments that represent higher levels of disability. A score of 0 represents a normal neurological exam, and 10 represents death due to MS.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events, Change in Vital Signs, Clinical Laboratory Test Results, 12-lead ECGs, USP Questionnaire, and C-SSRS Results	over 1 year	Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patient Global Impression of Change (PGIC)	week 60	Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.	units on a scale	MEAN
SECONDARY	Total Numeric-transformed Modified Ashworth Scale Score or the Most Affected Limb (TNmAS-MAL)	week 28	Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.	units on a scale	MEAN
SECONDARY	Expanded Disability Status Scale (EDSS)	week 60	Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Number of Participants With Adverse Events, Change in Vital Signs, Clinical Laboratory Test Results, 12-lead ECGs, USP Questionnaire, and C-SSRS Results	AERT 80 mg	276		Participants
Patient Global Impression of Change (PGIC)	AERT 80 mg	2.7	Standard Deviation 1.63	units on a scale
Total Numeric-transformed Modified Ashworth Scale Score or the Most Affected Limb (TNmAS-MAL)	AERT 80 mg	5.6	Standard Deviation 3.22	units on a scale
Expanded Disability Status Scale (EDSS)	AERT 80 mg	5.01	Standard Deviation 1.3	units on a scale

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AERT 80 mg	323
Overall Study	COMPLETED	AERT 80 mg	218
Overall Study	NOT COMPLETED	AERT 80 mg	105

Source ClinicalTrials.gov

Adverse events27

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
other	Nausea	Gastrointestinal disorders	AERT 80 mg	70	323
other	Vomiting	Gastrointestinal disorders	AERT 80 mg	29	323
other	Asthenia	General disorders	AERT 80 mg	61	323
other	Gait Disturbance	General disorders	AERT 80 mg	20	323
other	Muscular Weakness	Musculoskeletal and connective tissue disorders	AERT 80 mg	77	323
other	Dizziness	Nervous system disorders	AERT 80 mg	52	323
other	Somnolence	Nervous system disorders	AERT 80 mg	41	323
other	Headache	Nervous system disorders	AERT 80 mg	24	323
other	Urinary Tract Disorder	Renal and urinary disorders	AERT 80 mg	112	323
serious	Acute Myocardial Infarction	Cardiac disorders	AERT 80 mg	1	323

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AERT 80 mg	1	323
Total, other adverse events	AERT 80 mg	278	323
Total, serious adverse events	AERT 80 mg	21	323

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36861013	DERIVED

Source PubMed

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/NCT03319732

GET https://conductscience.org/api/trials/v1/NCT03319732/events?page=2

API reference For AI assistants