SpasticityPhase 3NCT05179577
A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
A Phase 3 study testing Arbaclofen in people with Spasticity, run by RVL Pharmaceuticals, Inc..
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spasticity
- What is being tested?
- Arbaclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Subjects 18 to 65 years of age, inclusive
- An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
- Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
- Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
- Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement
- Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects)
- Willing to sign the informed consent form (ICF)
Who cannot join
- Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
- In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
- Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
- Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
- Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
- Current malignancy or history of malignancy that has not been in remission for more than 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, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets (80 mg/day) in MS patients with spasticity. Arbaclofen ER will be compared with placebo. The treatment groups will be randomized in a 1:1 ratio. There will be a 49-day dose escalation period, followed by a 84-day maintenance treatment period, followed by a 21-day taper period.
- Conditions
- Spasticity
- Being tested
- Arbaclofen, Placebo
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArbaclofenDrug
Also called OS440, AERT
Arbaclofen Extended Release Tablets
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Arbaclofen Extended-Release | Active comparator | Extended-release oral tablet, twice daily dosing (80 mg/day) Receives: Drug: Arbaclofen |
| Placebo | Placebo comparator | Extended-release oral tablet, twice daily dosing Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)
The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The limb with the highest score is the most affected limb. Lower score is better. Scale is from 0 to 5.
Measured: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period
Responder status (AS-MAL-R) consists of three response categorical outcomes based on the Ashworth Scale (AS). Where the possible outcomes are: Strong Responder, Responder, or Non-Responder
Measured: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Secondary outcomes (4)
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL)
The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The total of the 4 limbs is the total limbs score. Lower score is better. Scale is from 0 to 5 per joint, Maximum score per limb is 15. Maximum total limbs score is 60.
Measured: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Clinician's global impression of change (CGIC) for Maintenance Treatment Period
The clinician makes a judgment about the change from baseline of illness severity, the subject's level of distress, other aspects of impairment, and the impact of the illness on functioning. Scale of -3 to +3, higher score is better
Measured: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period
The Numeric Rating Scale of Spasticity is a patient rated measure of the perceived severity of spasticity using a 0-10 numeric rating scale. Lower score is better.
Measured: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period
EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. Scale ranges from 0-10, in 0.5 unit increments. Lower score is better.
Measured: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
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
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RVL Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina deVries, PhD, Study director, RVL Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179577
- Sponsor's protocol ID
- OS440-3006
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)
- ClinicalTrials.gov ID
- NCT05179577
- Acronym / sponsor ID
- OS440-3006
- Conditions
- Spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- RVL Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 Jan 2022 (actual)
- 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, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets (80 mg/day) in MS patients with spasticity. Arbaclofen ER will be compared with placebo. The treatment groups will be randomized in a 1:1 ratio. There will be a 49-day dose escalation period, followed by a 84-day maintenance treatment period, followed by a 21-day taper period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arbaclofen Extended-Release | Active comparator | Drug: ArbaclofenExtended-release oral tablet, twice daily dosing (80 mg/day) |
| Placebo | Placebo comparator | Drug: PlaceboExtended-release oral tablet, twice daily dosing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects 18 to 65 years of age, inclusive
- An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
- Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
- Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
- Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement
Key exclusion criteria (7 listed)
- Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
- In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
- Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
- Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
- Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
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, AERTArbaclofen Extended Release Tablets | Drug | Arbaclofen Extended-Release |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)
Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The limb with the highest score is the most affected limb. Lower score is better. Scale is from 0 to 5.
Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period
Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Responder status (AS-MAL-R) consists of three response categorical outcomes based on the Ashworth Scale (AS). Where the possible outcomes are: Strong Responder, Responder, or Non-Responder
4 secondary outcomes
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL)
Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Clinician's global impression of change (CGIC) for Maintenance Treatment Period
Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period
Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period
Time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Tina deVries, PhD study director
RVL Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arbaclofen in people with Spasticity, run by RVL Pharmaceuticals, Inc..
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joann Stavole (9088091343, jstavole@rvlpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL) (time frame: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)). 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 3 Dec 2025.