A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS
- Conditions
- Spasticity, MuscleMultiple Sclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT03290131
- Lead Sponsor
- RVL Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 536
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AERT 40 mg Arbaclofen 40 mg Arbaclofen Extended-Release Tablets AERT 80 mg Arbaclofen 80 mg Arbaclofen Extended-Release Tablets Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL) 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.Clinical Global Impression of Change (CGIC) 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Neuro-Medic
🇵🇱Katowice, Poland
"MEDYK" Stanislaw Mazur Sp. z o.o. (LLC) Medical Centre
🇵🇱Rzeszów, Poland
Neurology Center Krzysztof Selmaj
🇵🇱Łódź, Poland
MED-Polonia, Sp. z o.o. (LLC)
🇵🇱Poznań, Poland
Minsk City Clinical Hospital #5
🇧🇾Minsk, Belarus
Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic Tokuda Hospital", Sofia, Neurology and Sleep Medicine Clinic
🇧🇬Sofia, Bulgaria
Grodno Regional Clinical Hospital
🇧🇾Grodno, Belarus
Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
🇧🇾Minsk, Belarus
University Clinical Centre of the Republic of Srpska, Clinic of Neurology
🇧🇦Banja Luka, Bosnia and Herzegovina
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Clinic of Neurological Diseases
🇧🇬Pleven, Bulgaria
Clinical Hospital Center Osijek, Clinic of Neurology
🇭🇷Osijek, Croatia
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Neurology Diseases
🇧🇬Sofia, Bulgaria
National Institute of Neurology and Neurosurgery
🇲🇩Chisinau, Moldova, Republic of
Medical Center "Rusemed" EOOD
🇧🇬Ruse, Bulgaria
Republican Research and Development Center for Neurology and Neurosurgery
🇧🇾Minsk, Belarus
Vitebsk Regional Diagnostic Center
🇧🇾Vitebsk, Belarus
Multiprofile Hospital for Active Treatment - Pleven within the structure of Military Medical Academy, Sofia
🇧🇬Pleven, Bulgaria
University Clinical Hospital Mostar, Clinic of Neurology
🇧🇦Mostar, Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia
🇧🇬Sofia, Bulgaria
Clinical Hospital Dubrava, Department of Neurology
🇭🇷Zagreb, Croatia
Clinical Hospital Center Rijeka, Department of Neurology
🇭🇷Rijeka, Croatia
Institute for Emergency Medicine
🇲🇩Chisinau, Moldova, Republic of
Dendryt Medical Center
🇵🇱Katowice, Poland
Medical Practice Professor K. Rejdak
🇵🇱Lublin, Poland
NeuroProtect Medical Center
🇵🇱Warsaw, Poland
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Clinical Hospital Center Zemun, Department of Neurology
🇷🇸Belgrade, Serbia
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Clinical Hospital Center Zvezdara
🇷🇸Belgrade, Serbia
General Hospital Varazdin, Department of Neurology
🇭🇷Varaždin, Croatia