Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
NCT ID: NCT01743651
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
353 participants
INTERVENTIONAL
2012-11-30
2014-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day
Baclofen
80 mg/day of Baclofen Tablets, USP
baclofen
80 mg/day as 20 mg baclofen administered orally 4 times per day
Arbaclofen
40 mg/day of Arbaclofen Tablets
arbaclofen
40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day
Interventions
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arbaclofen
40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day
baclofen
80 mg/day as 20 mg baclofen administered orally 4 times per day
Placebo
arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an established diagnosis (per McDonald Criteria) of Multiple Sclerosis (either relapsing remitting or secondary progressive course), that manifests spasticity for at least 6 months
* Spasticity due to MS as shown by a TNmAS score equal or greater than six (≥6) in the most affected limb.
* EDSS equal or greater than 3.0
* If receiving disease-modifying medications, these must have been at a stable dose for at least three (3) months prior to screening, and the subject must be willing to maintain this treatment for the duration of the study
* Stable regimen for at least thirty (30) days prior to study entry 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
* Have a creatinine clearance, as calculated by Glomerular Filtration Rate using the Modification of Diet in Renal Disease (MDRD) Study equation, greater than 60mL/min.
* Use of a medically highly effective of birth control during the study and for ninety (90) days thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects)
* Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study
Exclusion Criteria
* Inability to rate their level of spasticity or distinguish it from other MS symptoms
* Acute MS exacerbation requiring treatment within twelve (12) weeks of screening
* Use of intravenous methylprednisolone within the twelve (12) weeks before visit 1
* Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
* Use of botulinum toxin A or B within six (6) months of visit 1
* History of allergy to baclofen or any inactive component of test or reference formulation
* Pregnancy, lactation or planned pregnancy during the course of the study and for three (3) months thereafter.
* History of unstable psychiatric disease, or current signs and symptoms of significant medical disorders such as severe, progressive, or uncontrolled pulmonary, cardiac, gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine, immunologic, or neurological disease
* History of seizures
* Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
* Subjects with abnormal micturition that requires indwelling or intermittent catheterization or with lower urinary tract symptoms (LUTS) that result in a score greater than twenty-six (\>26) in the Baseline USP© questionnaire
* Current malignancy or history of malignancy that has not been in remission for more than five (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, put the subject at risk because of participation, influence the result of the study, or affect the subject's ability to participate
* Planned elective surgery or other procedures requiring general anesthesia during the study
* Subject who is inappropriate for placebo medication in the judgment of the Investigator
* History of substance abuse within the past twelve (12) months
* Current chronic use of long acting opioids or round the clock use of short acting opioids for the treatment of pain
* Participation in another research study within thirty (30) days of Screening
* Patients who are uncooperative or unwilling to sign consent form
18 Years
65 Years
ALL
No
Sponsors
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Osmotica Pharmaceutical US LLC
INDUSTRY
RVL Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Praveen Tyle, PhD
Role: STUDY_CHAIR
Osmotica Pharmaceutical
Locations
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Osmotica Study Site-138
Cullman, Alabama, United States
Osmotica Site-143
Long Beach, California, United States
Osmotica Study Site-123
Aurora, Colorado, United States
Osmotica Study Site-110
Bradenton, Florida, United States
Osmotica Study Site-142
Maitland, Florida, United States
Osmotica Study Site-119
Ormond Beach, Florida, United States
Osmotica Study Site-120
Pompano Beach, Florida, United States
Osmotica Study Site-109
Tampa, Florida, United States
Osmotica Study Site-126
Northbrook, Illinois, United States
Osmotica Study Site-108
Fort Wayne, Indiana, United States
Osmotica Study Site-116
Lenexa, Kansas, United States
Osmotica Study Site-124
Baltimore, Maryland, United States
Osmotica Study Site-136
Springfield, Massachusetts, United States
Osmotica Study Site-101
Ann Arbor, Michigan, United States
Osmotica Study Site-115
Johnson City, New York, United States
Osmotica Study Site-113
New York, New York, United States
Osmotica Study Site-141
New York, New York, United States
Osmotica Study Site-125
New York, New York, United States
Osmotica Study Site-106
Charlotte, North Carolina, United States
Osmotica Study Site-131
Cincinnati, Ohio, United States
Osmotica Study Site-127
Pittsburgh, Pennsylvania, United States
Osmotica Study Site-112
San Antonio, Texas, United States
Osmotica Study Site-133
Salt Lake City, Utah, United States
Osmotica Study Site-129
Seattle, Washington, United States
Osmotica SIte-144
Tacoma, Washington, United States
Osmotica Study Site-509
Pyatigorsk, Stavropol Kray, Russia
Osmotica Study Site-510
Tonnel’nyy, Stavropol Kray, Russia
Osmotica Site-511
Krasnoyarsk, , Russia
Osmotica Study Site-508
Krasnoyarsk, , Russia
Osmotica Study Site-510
Krasnoyarsk, , Russia
Osmotica Study Site-501
Moscow, , Russia
Osmotica Study Site-502
Moscow, , Russia
Osmotica Study Site-503
Saint Petersburg, , Russia
Osmotica Study Site-505
Saint Petersburg, , Russia
Osmotica Study Site-507
Saint Petersburg, , Russia
Osmotica Study Site-506
Sestroretsk, , Russia
Osmotica Study Site 614
Chernihiv, , Ukraine
Osmotica Study Site-602
Dnipropetrovsk, , Ukraine
Osmotica Study Site-603
Dnipropetrovsk, , Ukraine
Osmotica Study Site-609
Dnipropetrovsk, , Ukraine
Osmotica Study Site-611
Donetsk, , Ukraine
Osmotica Study Site-613
Ivano-Frankivsk, , Ukraine
Osmotica Site-605
Kharkiv, , Ukraine
Osmotica Study Site-610
Kharkiv, , Ukraine
Osmotica Study Site-604
Kharkiv, , Ukraine
Osmotica Study Site-606
Lviv, , Ukraine
Osmotica Study Site-608
Odesa, , Ukraine
Osmotica Study Site-615
Uzhhorod, , Ukraine
Countries
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Other Identifiers
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OS440-3002
Identifier Type: -
Identifier Source: org_study_id
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