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

PHASE3CompletedINTERVENTIONAL
Enrollment

536

Participants

Timeline

Start Date

January 28, 2018

Primary Completion Date

December 3, 2018

Study Completion Date

January 2, 2019

Conditions
Multiple SclerosisSpasticity, Muscle
Interventions
DRUG

Arbaclofen

Arbaclofen Extended Release Tablet

DRUG

Placebo

Placebo comparator

Trial Locations (30)

Unknown

Grodno Regional Clinical Hospital, Grodno

Minsk City Clinical Hospital #5, Minsk

Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology, Minsk

Republican Research and Development Center for Neurology and Neurosurgery, Minsk

Vitebsk Regional Diagnostic Center, Vitebsk

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

University Clinical Hospital Mostar, Clinic of Neurology, Mostar

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

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

"Medical Center Rusemed EOOD", Rousse

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

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

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

Clinical Hospital Center Osijek, Clinic of Neurology, Osijek

Clinical Hospital Center Rijeka, Department of Neurology, Rijeka

General Hospital Varazdin, Department of Neurology, Varaždin

Clinical Hospital Dubrava, Department of Neurology, Zagreb

Institute for Emergency Medicine, Chisinau

National Institute of Neurology and Neurosurgery, Chisinau

Dendryt Medical Center, Katowice

Neuro-Medic, Katowice

Neurology Center Krzysztof Selmaj, Lodz

Medical Practice Professor K. Rejdak, Lublin

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

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

NeuroProtect Medical Center, Warsaw

Clinical Center of Serbia, Belgrade

Clinical Hospital Center Zemun, Department of Neurology, Belgrade

Clinical Hospital Center Zvezdara, Belgrade

Clinical Center Kragujevac, Kragujevac

Sponsors
All Listed Sponsors
collaborator

Osmotica Pharmaceutical US LLC

INDUSTRY

lead

RVL Pharmaceuticals, Inc.

INDUSTRY