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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03290131
Other study ID # OS440-3004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 28, 2018
Est. completion date January 2, 2019

Study information

Verified date May 2022
Source RVL Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 536
Est. completion date January 2, 2019
Est. primary completion date December 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
Arbaclofen
Arbaclofen Extended Release Tablet
Placebo
Placebo comparator

Locations

Country Name City State
Belarus 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
Bosnia and Herzegovina University Clinical Centre of the Republic of Srpska, Clinic of Neurology Banja Luka
Bosnia and Herzegovina University Clinical Hospital Mostar, Clinic of Neurology Mostar
Bulgaria 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 Ruse
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
Croatia 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
Moldova, Republic of Institute for Emergency Medicine Chisinau
Moldova, Republic of National Institute of Neurology and Neurosurgery Chisinau
Poland Dendryt Medical Center Katowice
Poland Neuro-Medic Katowice
Poland Neurology Center Krzysztof Selmaj Lódz
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
Serbia 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

Sponsors (2)

Lead Sponsor Collaborator
RVL Pharmaceuticals, Inc. Osmotica Pharmaceutical US LLC

Countries where clinical trial is conducted

Belarus,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Moldova, Republic of,  Poland,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL) 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.
84 days
Primary Clinical Global Impression of Change (CGIC) 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). 84 days
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