A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS (OS440-3004)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03290131 |
Recruitment Status :
Completed
First Posted : September 21, 2017
Last Update Posted : September 9, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis Spasticity, Muscle | Drug: Arbaclofen Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 536 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 28, 2018 |
Actual Primary Completion Date : | December 3, 2018 |
Actual Study Completion Date : | January 2, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: AERT 40 mg
40 mg Arbaclofen Extended-Release Tablets
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Drug: Arbaclofen
Arbaclofen is the active R enantiomer of baclofen. |
Active Comparator: AERT 80 mg
80 mg Arbaclofen Extended-Release Tablets
|
Drug: Arbaclofen
Arbaclofen is the active R enantiomer of baclofen. |
Placebo Comparator: Placebo
Placebo
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Drug: Placebo
Placebo comparator |
- total numeric-transformed modified Ashworth Scale score of the most affected limb (TNmAS-MAL) [ Time Frame: 84 days ]The TNmAS is considered the primary clinical measure of muscle spasticity in subjects with neurological conditions. It is a useful 6-point rating scale to measure abnormality in tone or the resistance to passive movements
- Clinical Global Impression of Change (CGIC) [ Time Frame: 84 days ]The CGIC was developed for use in National Institute of Mental Health (NIMH)-sponsored clinical trials 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 CGIC scale will be used to measure the overall change in the subject's condition since starting the study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria Includes:
- Subjects 18 to 65 years of age, inclusive.
- An established diagnosis of MS that manifests a documented history of spasticity.
- If receiving disease-modifying medications (eg, interferons approved for MS, glatiramer acetate, natalizumab, fingolimod, or mitoxantrone), there must be no change in dose for at least 3 months prior to Visit 1 (Screening), and the subject must be willing to maintain this treatment dose for the duration of the study. If receiving AMPYRA® (dalfampridine, fampridine, 4-amino puridine), subject must be at a stable dose for at least 3 months prior to Visit 1.
- Stable regimen for at least 3 months prior to Visit 2 for all medications and non-pharmacological therapies that are intended to alleviate spasticity.
- 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 Includes:
- Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity.
- 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.
- Subject has clinically significant abnormal laboratory values, in the opinion of the investigator, at Visit 1 or Visit 2.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290131

Study Director: | David Jacobs, MD | Vice President |
Responsible Party: | Osmotica Pharmaceutical US LLC |
ClinicalTrials.gov Identifier: | NCT03290131 |
Other Study ID Numbers: |
OS440-3004 |
First Posted: | September 21, 2017 Key Record Dates |
Last Update Posted: | September 9, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Muscle Spasticity Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations |