SpasticityPhase 3NCT01743651
Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
A Phase 3 study testing arbaclofen and baclofen in people with Spasticity and Multiple Sclerosis, run by RVL Pharmaceuticals, Inc. at 48 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spasticity, Multiple Sclerosis
- What is being tested?
- arbaclofen and baclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 353 participants
- Where
- 48 sitesin 3 countries
- Study dates
- Nov 2012to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (male or female) 18 to 65 years of age, inclusive, at the time of dosing
- 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
Show all 10Show fewer
- 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
Who cannot join
- Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
48 sites in 3 countries.
48 sites in 3 countries
United States25 sites
Osmotica Study Site-101
Ann Arbor, Michigan, 48104
Osmotica Study Site-123
Aurora, Colorado, 80045
Osmotica Study Site-124
Baltimore, Maryland, 21201
Osmotica Study Site-110
Bradenton, Florida, 34205
Osmotica Study Site-106
Charlotte, North Carolina, 28204
Osmotica Study Site-131
Cincinnati, Ohio, 45219
Osmotica Study Site-138
Cullman, Alabama, 35058
Osmotica Study Site-108
Fort Wayne, Indiana, 46805
Osmotica Study Site-115
Johnson City, New York, 13790
Osmotica Study Site-116
Lenexa, Kansas, 66214
Osmotica Site-143
Long Beach, California, 92845
Osmotica Study Site-142
Maitland, Florida, 32751
Osmotica Study Site-113
New York, New York, 10016
Osmotica Study Site-141
New York, New York, 10019
Osmotica Study Site-125
New York, New York, 10029
Osmotica Study Site-126
Northbrook, Illinois, 60096
Osmotica Study Site-119
Ormond Beach, Florida, 32174
Osmotica Study Site-127
Pittsburgh, Pennsylvania, 15212
Osmotica Study Site-120
Pompano Beach, Florida, 33060
Osmotica Study Site-133
Salt Lake City, Utah, 84103
Osmotica Study Site-112
San Antonio, Texas, 78229
Osmotica Study Site-129
Seattle, Washington, 98122
Osmotica Study Site-136
Springfield, Massachusetts, 01104
Osmotica SIte-144
Tacoma, Washington, 98405
Osmotica Study Site-109
Tampa, Florida, 33606
Ukraine12 sites
Osmotica Study Site 614
Chernihiv, 14001
Osmotica Study Site-602
Dnipropetrovsk, 49005
Osmotica Study Site-603
Dnipropetrovsk, 49022
Osmotica Study Site-609
Dnipropetrovsk, 53012
Osmotica Study Site-611
Donetsk, 83003
Osmotica Study Site-613
Ivano-Frankivsk, 76008
Osmotica Site-605
Kharkiv, 61068
Osmotica Study Site-610
Kharkiv, 61103
Osmotica Study Site-604
Kharkiv
Osmotica Study Site-606
Lviv
Osmotica Study Site-608
Odesa
Osmotica Study Site-615
Uzhhorod, 88018
Russia11 sites
Osmotica Site-511
Krasnoyarsk
Osmotica Study Site-508
Krasnoyarsk
Osmotica Study Site-510
Krasnoyarsk
Osmotica Study Site-501
Moscow
Osmotica Study Site-502
Moscow
Osmotica Study Site-509
Pyatigorsk, Stavropol Kray
Osmotica Study Site-503
Saint Petersburg
Osmotica Study Site-505
Saint Petersburg
Osmotica Study Site-507
Saint Petersburg
Osmotica Study Site-506
Sestroretsk
Osmotica Study Site-510
Tonnel’nyy, Stavropol Kray
About this study
Official title: A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis
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.
Read the detailed description
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.
- Conditions
- Spasticity, Multiple Sclerosis
- Being tested
- arbaclofen, baclofen, Placebo
- Keywords
- spasticity, multiple sclerosis, arbaclofen
- Medical subject headings
- Muscle Spasticity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arbaclofenDrug
Also called OS440, AERT
40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day
baclofenDrug
80 mg/day as 20 mg baclofen administered orally 4 times per day
PlaceboDrug
arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Baclofen | Active comparator | 80 mg/day of Baclofen Tablets, USP Receives: Drug: baclofen |
| Arbaclofen | Experimental | 40 mg/day of Arbaclofen Tablets Receives: Drug: arbaclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Visit 9 (120 days) or end of study
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline to Visit 4 (22 days), Visit 5 (36 days) Visit 6 (50 days) Visit 7 (71 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- RVL Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Osmotica Pharmaceutical US LLC
- Responsible party
- Sponsor
- Investigators
- Praveen Tyle, PhD, Study chair, Osmotica Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743651
- Sponsor's protocol ID
- OS440-3002
- Status last verified
- May 2014
- First submitted
- 28 Nov 2012
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01743651
- Acronym / sponsor ID
- OS440-3002
- Conditions
- Spasticity, Multiple Sclerosis
- Keywords
- spasticity, multiple sclerosis, arbaclofen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- RVL Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Osmotica Pharmaceutical US LLC
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Baclofen | Active comparator | Drug: baclofen80 mg/day of Baclofen Tablets, USP |
| Arbaclofen | Experimental | Drug: arbaclofen40 mg/day of Arbaclofen Tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients (male or female) 18 to 65 years of age, inclusive, at the time of dosing
- 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
Key exclusion criteria (20 listed)
- Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arbaclofenAlso: OS440, AERT40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day | Drug | Arbaclofen |
| baclofen80 mg/day as 20 mg baclofen administered orally 4 times per day | Drug | Baclofen |
| Placeboarbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day | Drug | Placebo |
Primary outcome
Efficacy as determined by Total Numeric Transformed Modified Ashworth scale (TNmAS) in the most affected limb.
Time frame: Change in baseline from Visit 1 through Visit 9 (120 days) or end of treatment
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.
Clinical Global Impression of Change (CGIC) through end of treatment
Time frame: Visit 9 (120 days) or end of study
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.
9 secondary outcomes
Changes in the Multiple Sclerosis Spasticity Scale (MSSS-88)
Time frame: Baseline through Visit 9 (120 days)
Changes in the TNmAS for the most affected limb
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
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)
Time frame: Baseline to Visit 9 (120 Days)
Changes in the Lower Extremity Manual Muscle Testing (LEMMT) Scale
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)
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
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
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)
Time frame: Baseline to Visit 4 (22 days), Visit 5 (36 days) Visit 6 (50 days) Visit 7 (71 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Tyle, PhD study chair
Osmotica Pharmaceutical
48 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing arbaclofen and baclofen in people with Spasticity and Multiple Sclerosis, run by RVL Pharmaceuticals, Inc. at 48 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Ukraine, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as determined by Total Numeric Transformed Modified Ashworth scale (TNmAS) in the most affected limb. (time frame: Change in baseline from Visit 1 through Visit 9 (120 days) or end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.