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

NCT ID: NCT03290131

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-28
• Study Completion Date: 2019-01-02

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.

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.

Conditions

Multiple Sclerosis; Spasticity, Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AERT 40 mg

40 mg Arbaclofen Extended-Release Tablets

Group Type: ACTIVE_COMPARATOR

Arbaclofen

Intervention Type: DRUG

Arbaclofen Extended Release Tablet

AERT 80 mg

80 mg Arbaclofen Extended-Release Tablets

Group Type: ACTIVE_COMPARATOR

Arbaclofen

Intervention Type: DRUG

Arbaclofen Extended Release Tablet

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Interventions

Arbaclofen

Arbaclofen Extended Release Tablet

Intervention Type: DRUG

Placebo

Placebo comparator

Intervention Type: DRUG

Other Intervention Names

AERT

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osmotica Pharmaceutical US LLC

INDUSTRY

Sponsor Role: collaborator

RVL Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Jacobs, MD

Role: STUDY_DIRECTOR

Vice President

Locations

Grodno Regional Clinical Hospital

Grodno, , Belarus

Minsk City Clinical Hospital #5

Minsk, , Belarus

Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology

Minsk, , Belarus

Republican Research and Development Center for Neurology and Neurosurgery

Minsk, , Belarus

Vitebsk Regional Diagnostic Center

Vitebsk, , Belarus

University Clinical Centre of the Republic of Srpska, Clinic of Neurology

Banja Luka, , Bosnia and Herzegovina

University Clinical Hospital Mostar, Clinic of Neurology

Mostar, , Bosnia and Herzegovina

Multiprofile Hospital for Active Treatment - Pleven within the structure of Military Medical Academy, Sofia

Pleven, , Bulgaria

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Clinic of Neurological Diseases

Pleven, , Bulgaria

Medical Center "Rusemed" EOOD

Rousse, , Bulgaria

Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic Tokuda Hospital", Sofia, Neurology and Sleep Medicine Clinic

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Neurology Diseases

Sofia, , Bulgaria

Clinical Hospital Center Osijek, Clinic of Neurology

Osijek, , Croatia

Clinical Hospital Center Rijeka, Department of Neurology

Rijeka, , Croatia

General Hospital Varazdin, Department of Neurology

Varaždin, , Croatia

Clinical Hospital Dubrava, Department of Neurology

Zagreb, , Croatia

Institute for Emergency Medicine

Chisinau, , Moldova

National Institute of Neurology and Neurosurgery

Chisinau, , Moldova

Dendryt Medical Center

Katowice, , Poland

Neuro-Medic

Katowice, , Poland

Neurology Center Krzysztof Selmaj

Lodz, , Poland

Medical Practice Professor K. Rejdak

Lublin, , Poland

MED-Polonia, Sp. z o.o. (LLC)

Poznan, , Poland

"MEDYK" Stanislaw Mazur Sp. z o.o. (LLC) Medical Centre

Rzeszów, , Poland

NeuroProtect Medical Center

Warsaw, , Poland

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Hospital Center Zemun, Department of Neurology

Belgrade, , Serbia

Clinical Hospital Center Zvezdara

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Countries

Belarus; Bosnia and Herzegovina; Bulgaria; Croatia; Moldova; Poland; Serbia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OS440-3004

Identifier Type: -

Identifier Source: org_study_id