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A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS (OS440-3004)

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
Results First Posted : July 15, 2022
Last Update Posted : July 15, 2022
Sponsor:
Collaborator:
Osmotica Pharmaceutical US LLC
Information provided by (Responsible Party):
RVL Pharmaceuticals, Inc.

Study Description
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Brief Summary:
Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic disability in adults in North America. Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Spasticity, Muscle Drug: Arbaclofen Drug: Placebo Phase 3

Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral AERT in MS patients with spasticity. Two doses of AERT, 40 mg and 80 mg, will be compared with placebo. The treatment groups will be randomized in a 1:1:1 ratio. Eligible patients will undergo a washout period for withdrawal of all medications used for anti-spasticity and/or muscle relaxation prior to randomization. A baseline clinical evaluation will be performed (Visit 2) to confirm eligibility for study randomization, and subjects will be randomly assigned to 1 of 3 treatment arms. Subjects will remain on maintenance treatment for approximately 3 months.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AERT 40 mg
40 mg Arbaclofen Extended-Release Tablets
 Drug: Arbaclofen
Arbaclofen Extended Release Tablet
Other Name: AERT
Active Comparator: AERT 80 mg
80 mg Arbaclofen Extended-Release Tablets
 Drug: Arbaclofen
Arbaclofen Extended Release Tablet
Other Name: AERT
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL) [ Time Frame: 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.


  2. Clinical Global Impression of Change (CGIC) [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
RVL Pharmaceuticals, Inc.
Osmotica Pharmaceutical US LLC
Investigators
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Study Director: David Jacobs, MD Vice President
  Study Documents (Full-Text)

Documents provided by RVL Pharmaceuticals, Inc.:
Study Protocol  [PDF] November 9, 2017
Statistical Analysis Plan  [PDF] January 28, 2019

More Information
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Responsible Party: RVL Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03290131    
Other Study ID Numbers: OS440-3004
First Posted: September 21, 2017    Key Record Dates
Results First Posted: July 15, 2022
Last Update Posted: July 15, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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