A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS (OS440-3005)
|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: NCT03319732|
Recruitment Status : Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Spasticity, Muscle||Drug: Arbaclofen||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||323 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)|
|Actual Study Start Date :||April 3, 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: AERT 80 mg
Arbaclofen extended release tablet, 20 mg
Arbaclofen is the active R enantiomer of baclofen.
Other Name: AERT
- Evaluate the long-term safety and tolerability of AERT through the number of patients with treatment-emergent adverse events mapped to the Medical Dictionary for Regulatory Activities (MedDRA) SOCs and PTs. [ Time Frame: over 1 year ]Descriptive statistics will be used to summarize study data.
- Patient Global Impression of Change (PGIC) [ Time Frame: over 1 year ]Patient Global impression of Change (PGIC) is a scale to evaluate the change in activity limitations, symptoms, emotions, and overall quality of life using scores from 1-7 with 1 being no change and 7 being a great deal better, and a considerable improvement that has made all the difference.
- Total Numeric-transformed modified Ashworth Scale score or the most affected limb (TNmAS-MAL) [ Time Frame: over 1 year ]The TNmAS is considered the primary clinical measure of muscle spasticity in subjects with neurological conditions. It is a useful 6-point rating scale to measure abnormality in tone or the resistance to passive movements.
- Expanded Disability Status Scale (EDSS) [ Time Frame: over 1 year ]Expanded Disability Status Scale (EDSS) is a method of quantifying disability in MS and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5-unit increments that represent higher levels of disability. A score of 0 represents a normal neurological exam and 10 represents death due to MS.
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): NCT03319732
|United States, California|
|Neuro Pain Medical Center|
|Fresno, California, United States, 93710|
|Study Director:||David Jacobs, MD||Vice President|