A Phase 3 interventional study of arbaclofen and baclofen in Spasticity and Multiple Sclerosis, sponsored by RVL Pharmaceuticals, Inc.. Completed at 48 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by RVL Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity.
Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks.
This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity.
Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks with the final study visit occurring at 19 weeks from start of achieving the target dose or 22 weeks from the Study Visit 1.
713 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.
This study's enrollment of 353 is above the median of 36 across 532 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →RVL Pharmaceuticals, Inc. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Placebo
Drug: Placebo
80 mg/day of Baclofen Tablets, USP
Drug: baclofen
40 mg/day of Arbaclofen Tablets
Drug: arbaclofen
40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day
Also known as: OS440, AERT
80 mg/day as 20 mg baclofen administered orally 4 times per day
arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day
Efficacy as determined by Total Numeric Transformed Modified Ashworth scale (TNmAS) in the most affected limb.
Change from baseline through end of treatment in the pre-dose, morning TNmAS of the most affected limb. The most affected limb is determined at baseline using the sum of scores for three major motor groups. High scores indicate more severe spasticity.
Time frame: Change in baseline from Visit 1 through Visit 9 (120 days) or end of treatment
Clinical Global Impression of Change (CGIC) through end of treatment
The CGIC is a global rating scale that captures the investigator's assessment of the subject's change in overall functional performance since starting the study. Scores range from -3 (significant worsening) to +3 (significant improvement.
Time frame: Visit 9 (120 days) or end of study
Changes in the Multiple Sclerosis Spasticity Scale (MSSS-88)
This MSSS-88 is a self-administered questionnaire for the subject to assess overall functional performance and sense of impairment with respect to the level of spasticity.
Time frame: Baseline through Visit 9 (120 days)
Changes in the TNmAS for the most affected limb
The modified Ashworth Scale is a six (6)-point rating scale that measures abnormality in tone or the resistance to passive movements. Measurements are made in three muscle groups of each limb. The most affect limb is determined at baseline, based on the sum of scores from each limb. Higher scores indicate more severe spasticity.
Time frame: From baseline to visits 4 (22 days), 5 (36 days), 6 (50 days), 7 (71 days), and 9 (120 days)
Changes in the TNmAS for the sum of all limbs
The sums of scores from all limbs are compared to the baseline sum. Higher scores indicate more severe spasticity.
Time frame: Baseline to visits 4 (22 days), 5 (36 days), 6 (50 days), 7 (71 days), and 9 (120 days)
Changes in Expanded Disability Status Score (EDSS)
The EDSS is based on an examination by a neurologist with a scale that ranges from zero (0) to ten (10) in half point (0.5) unit increments. Higher scores represent higher levels of disability.
Time frame: Baseline to Visit 9 (120 Days)
Changes in the Lower Extremity Manual Muscle Testing (LEMMT) Scale
The LEMMT Scale is an evaluation of the function and strength of individual muscles and muscle groups based on effective performance of limb movement in relation to the forces of gravity and manual resistance. Maximum muscular strength is the maximum amount of tension or force that a muscle or muscle group can voluntarily exert in one maximal effort. Scores for each muscle or muscle group range from 0 (no detectable activity) to 5 (normal activity).
Time frame: Baseline to Visit 4 (22 days), Visit 5 (36 days) Visit 6 (50 days) Visit 7 (71 days) and Visit 9 (120 days)
Changes in Epworth Sleepiness Scale (ESS)
The ESS is used to determine the level of daytime sleepiness. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 in eight different situations.
Time frame: Baseline to Visit 4 (22 days), Visit 5 (36 days) Visit 6 (50 days) Visit 7 (71 days) and Visit 9 (120 days)
Changes in the subject-recorded mean daily Drowsiness Numerical Rating Scale (DNRS)score for the day prior to each visit
Drowsiness will be reported by the subject using a numerical rating scale with a range of zero (0; no drowsiness) to ten (10; worst possible drowsiness). Scores will be recorded every 3 hours during the day before each designated visit.
Time frame: Baseline to Visit 4 (22 days), Visit 5 (36 days) Visit 6 (50 days) Visit 7 (71 days) and Visit 9 (120 days)
Changes in the Urinary Symptom Profile (USP) Scale
The USP is a Health-Related Quality of Life questionnaire composed of 13 items assessing urinary symptoms in adults with stress, urge, overactive bladder, or urinary obstructive symptoms.
Time frame: Baseline to Visit 4 (22 days), Visit 5 (36 days) Visit 6 (50 days) Visit 7 (71 days) and Visit 9 (120 days)
Clinical Global Impression of Change (CGIC)
The CGIC scores will be recorded at the designated intervals prior to Visit 9 (end of study)
Time frame: Baseline to Visit 4 (22 days), Visit 5 (36 days) Visit 6 (50 days) Visit 7 (71 days)
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Arbaclofen
RVL Pharmaceuticals, Inc.