Trial Outcomes & Findings for A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS (NCT NCT03319732)
NCT ID: NCT03319732
Last Updated: 2022-08-09
Results Overview
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.
COMPLETED
PHASE3
323 participants
over 1 year
2022-08-09
Participant Flow
Participant milestones
| Measure |
AERT 80 mg
Arbaclofen extended release tablet, 20 mg (Two 20-mg tablets twice daily for a total of 80 mg daily dose)
|
|---|---|
|
Overall Study
STARTED
|
323
|
|
Overall Study
COMPLETED
|
218
|
|
Overall Study
NOT COMPLETED
|
105
|
Reasons for withdrawal
| Measure |
AERT 80 mg
Arbaclofen extended release tablet, 20 mg (Two 20-mg tablets twice daily for a total of 80 mg daily dose)
|
|---|---|
|
Overall Study
Adverse Event
|
40
|
|
Overall Study
Withdrawal by Subject
|
50
|
|
Overall Study
MS relapse
|
10
|
|
Overall Study
reason not specified
|
5
|
Baseline Characteristics
A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS
Baseline characteristics by cohort
| Measure |
AERT 80 mg
n=323 Participants
Arbaclofen extended release tablet, 20 mg
Arbaclofen: Arbaclofen is the active R enantiomer of baclofen.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
323 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
312 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Height
|
169.6 cm
STANDARD_DEVIATION 8.94 • n=99 Participants
|
|
Weight
|
71.67 kg
STANDARD_DEVIATION 15.704 • n=99 Participants
|
|
Body Mass Index (BMI)
|
24.825 "kg/m^2"
STANDARD_DEVIATION 4.7760 • n=99 Participants
|
|
Total Numeric-Transformed Modified Ashworth Scale-Total Limbs (TNmAS-TL)
|
13.0 units on a scale
STANDARD_DEVIATION 8.06 • n=99 Participants
|
|
Total Numeric-Transformed Modified Ashworth Scale-Most Affected Limb (TNmAS-MAL)
|
6.3 units on a scale
STANDARD_DEVIATION 3.25 • n=99 Participants
|
|
Expanded Disability Status Scale (EDSS)
|
4.98 units on a scale
STANDARD_DEVIATION 1.29 • n=99 Participants
|
|
Patient Global Impression of Change (PGIC)
|
3.3 units on a scale
STANDARD_DEVIATION 1.61 • n=99 Participants
|
PRIMARY outcome
Timeframe: over 1 yearPopulation: Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.
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.
Outcome measures
| Measure |
AERT 80 mg
n=323 Participants
Arbaclofen extended release tablet, 20 mg (two 20 mg tablets twice a day for a total of 80 mg daily dose)
|
|---|---|
|
Number of Participants With Adverse Events, Change in Vital Signs, Clinical Laboratory Test Results, 12-lead ECGs, USP Questionnaire, and C-SSRS Results
|
276 Participants
|
SECONDARY outcome
Timeframe: week 60Population: Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.
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.
Outcome measures
| Measure |
AERT 80 mg
n=323 Participants
Arbaclofen extended release tablet, 20 mg (two 20 mg tablets twice a day for a total of 80 mg daily dose)
|
|---|---|
|
Patient Global Impression of Change (PGIC)
|
2.7 units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: week 28Population: Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.
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.
Outcome measures
| Measure |
AERT 80 mg
n=323 Participants
Arbaclofen extended release tablet, 20 mg (two 20 mg tablets twice a day for a total of 80 mg daily dose)
|
|---|---|
|
Total Numeric-transformed Modified Ashworth Scale Score or the Most Affected Limb (TNmAS-MAL)
|
5.6 units on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: week 60Population: Safety population included all subjects who received at least one dose of study treatment and had at least one-post dose visit.
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.
Outcome measures
| Measure |
AERT 80 mg
n=323 Participants
Arbaclofen extended release tablet, 20 mg (two 20 mg tablets twice a day for a total of 80 mg daily dose)
|
|---|---|
|
Expanded Disability Status Scale (EDSS)
|
5.01 units on a scale
Standard Deviation 1.3
|
Adverse Events
AERT 80 mg
Serious adverse events
| Measure |
AERT 80 mg
n=323 participants at risk
Arbaclofen extended release tablet, 20 mg
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.31%
1/323 • 60 weeks
|
|
Cardiac disorders
Myocardial Infarction
|
0.31%
1/323 • 60 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.31%
1/323 • 60 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.31%
1/323 • 60 weeks
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.31%
1/323 • 60 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.31%
1/323 • 60 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.31%
1/323 • 60 weeks
|
|
Infections and infestations
Toxicity to various agents
|
0.31%
1/323 • 60 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.31%
1/323 • 60 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.31%
1/323 • 60 weeks
|
|
Nervous system disorders
Multiple Sclerosis relapse
|
2.2%
7/323 • 60 weeks
|
|
Nervous system disorders
Paraparesis
|
0.31%
1/323 • 60 weeks
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.31%
1/323 • 60 weeks
|
|
Nervous system disorders
Somnolence
|
0.31%
1/323 • 60 weeks
|
|
Renal and urinary disorders
Atonic Urinary Bladder
|
0.31%
1/323 • 60 weeks
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.31%
1/323 • 60 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.31%
1/323 • 60 weeks
|
|
Vascular disorders
Hypertension
|
0.31%
1/323 • 60 weeks
|
Other adverse events
| Measure |
AERT 80 mg
n=323 participants at risk
Arbaclofen extended release tablet, 20 mg
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
21.7%
70/323 • 60 weeks
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
29/323 • 60 weeks
|
|
General disorders
Asthenia
|
18.9%
61/323 • 60 weeks
|
|
General disorders
Gait Disturbance
|
6.2%
20/323 • 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
23.8%
77/323 • 60 weeks
|
|
Nervous system disorders
Dizziness
|
16.1%
52/323 • 60 weeks
|
|
Nervous system disorders
Somnolence
|
12.7%
41/323 • 60 weeks
|
|
Nervous system disorders
Headache
|
7.4%
24/323 • 60 weeks
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
34.7%
112/323 • 60 weeks
|
Additional Information
Vice President Regulatory Affairs and Quality
RVL Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place