Multiple SclerosisPhase 3NCT01359566
Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
A Phase 3 study testing Arbaclofen placarbil 15 mg BID, Arbaclofen placarbil 30 mg BID and Arbaclofen placarbil 45 mg BID in people with Multiple Sclerosis, run by XenoPort, Inc. at 28 sites in United States.
Trial summary
To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Arbaclofen placarbil 15 mg BID, Arbaclofen placarbil 30 mg BID and Arbaclofen placarbil 45 mg BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 28 sitesUnited States
- Study dates
- May 2011to Feb 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has multiple sclerosis (MS) based on Poser or McDonald Criteria (all subtypes of MS will be accepted, including relapsing remitting, primary or secondary progressive, if disease is stable per exclusion criteria).
- Maximum Ashworth Score Scale score of ≥ 2 in at least one of the following muscle groups on either side of the body: hip abductors/adductors, knee flexors/extensors, ankle flexors/extensors.
- Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.
- If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study.
- Spasticity Disability Rating of 2 or higher at Baseline.
- Willing to discontinue and refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity (including, but not limited to, baclofen, tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid and cannabis).
Who cannot join
- Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
- Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
- Subjects who have suffered an acute relapse of MS (as determined by the Investigator) within 90 days prior to Screening, or have had more than 1 relapse within the year prior to Screening
- Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.
- Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
- Subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits
Show all 10Show fewer
- Gabapentin ≤ 1800 mg per day or pregabalin ≤ 150 mg per day
- Amitriptyline ≤ 75 mg per day or nortriptyline ≤ 75 mg per day
- Opioids ≤ 30 mg morphine equivalents per day.
- Evidence of unstable or severe systemic illness, including but not limited to: Cardiovascular disease (e.g., chronic ventricular arrhythmia, unstable angina or CHF), respiratory disease (e.g., sleep apnea, COPD requiring oxygen therapy or hospitalization in last year), endocrine disease, hepatic disease (e.g., chronic active hepatitis), renal disease, or immunodeficiency.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
XenoPort Clinical Site
Akron, Ohio, 44320
XenoPort Clinical Site
Albany, New York, 12208
XenoPort Clinical Site
Albuquerque, New Mexico, 87102
XenoPort Clinical Site
Asheville, North Carolina, 28805
XenoPort Clinical Site
Berkeley, California, 94705
XenoPort Clinical Site
Bingham Farms, Michigan, 48025
XenoPort Clinical Site
Denver, Colorado, 80012
XenoPort Clinical Site
Detroit, Michigan, 48202
XenoPort Clinical Site
Franklin, Tennessee, 37064
XenoPort Clinical Site
Indianapolis, Indiana, 46204
XenoPort Clinical Site
Lake Barrington, Illinois, 60010
XenoPort Clinical Site
Lenexa, Kansas, 66210
XenoPort Clinical Site
Lexington, Kentucky, 40505
XenoPort Clinical Site
Nashville, Tennessee, 37205
XenoPort Clinical Site
Patchogue, New York, 11772
XenoPort Clinical Site
Phoenix, Arizona, 85004
XenoPort Clinical Site
Plainview, New York, 11803
XenoPort Clinical Site
Port Charlotte, Florida, 33948
XenoPort Clinical Site
San Antonio, Texas, 78206
XenoPort Clinical Site
San Diego, California, 92103
XenoPort Clinical Site
Sarasota, Florida, 34231
XenoPort Clinical Site
Seattle, Washington, 98108
XenoPort Clinical Site
St. Petersburg, Florida, 33701
XenoPort Clinical Site
Tacoma, Washington, 98404
XenoPort Clinical Site
Tampa, Florida, 33604
XenoPort Clinical Site
Toms River, New Jersey, 08753
XenoPort Clinical Site
Tucson, Arizona, 85701
XenoPort Clinical Site
Vienna, Virginia, 22181
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).
- Conditions
- Multiple Sclerosis
- Being tested
- Arbaclofen placarbil 15 mg BID, Placebo, Arbaclofen placarbil 30 mg BID, Arbaclofen placarbil 45 mg BID
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arbaclofen placarbil 15 mg BIDDrug
Also called XP19986 SR4
arbaclofen placarbil 15 mg BID
PlaceboDrug
Also called Sugar Pill
Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
Arbaclofen placarbil 30 mg BIDDrug
Also called XP19986 SR4
arbaclofen placarbil 30 mg BID
Arbaclofen placarbil 45 mg BIDDrug
Also called XP19986 SR4
arbaclofen placarbil 45 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Arbaclofen placarbil 15 mg BID | Active comparator | Arbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening Receives: Drug: Arbaclofen placarbil 15 mg BID |
| Arbaclofen placarbil 30 mg BID | Active comparator | Arbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening Receives: Drug: Arbaclofen placarbil 30 mg BID |
| Arbaclofen placarbil 45 mg BID | Active comparator | Arbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening Receives: Drug: Arbaclofen placarbil 45 mg BID |
| Placebo | Placebo comparator | Placebo every morning and every evening Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)
numerical score
Measured: 10-weeks
Patient Global Impression of Change (PGIC) score
numerical score
Measured: 10-weeks
Secondary outcomes (3)
Change in the overall Modified PRISM score
Variables
Measured: Weeks 4, 6, 10
Change in weekly average severity of pain score associated with muscle spasm.
numerical score
Measured: Week 10
Change in weekly average VAS score of sleep quality
numerical score
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359566
- Sponsor's protocol ID
- XP-B-089
- Status last verified
- Feb 2021
- First submitted
- 22 May 2011
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01359566
- Acronym / sponsor ID
- XP-B-089
- Conditions
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 May 2011 (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.
To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arbaclofen placarbil 15 mg BID | Active comparator | Drug: Arbaclofen placarbil 15 mg BIDArbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening |
| Arbaclofen placarbil 30 mg BID | Active comparator | Drug: Arbaclofen placarbil 30 mg BIDArbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening |
| Arbaclofen placarbil 45 mg BID | Active comparator | Drug: Arbaclofen placarbil 45 mg BIDArbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo every morning and every evening |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has multiple sclerosis (MS) based on Poser or McDonald Criteria (all subtypes of MS will be accepted, including relapsing remitting, primary or secondary progressive, if disease is stable per exclusion criteria).
- Maximum Ashworth Score Scale score of ≥ 2 in at least one of the following muscle groups on either side of the body: hip abductors/adductors, knee flexors/extensors, ankle flexors/extensors.
- Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.
- If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study.
- Spasticity Disability Rating of 2 or higher at Baseline.
Key exclusion criteria (10 listed)
- Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
- Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
- Subjects who have suffered an acute relapse of MS (as determined by the Investigator) within 90 days prior to Screening, or have had more than 1 relapse within the year prior to Screening
- Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.
- Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
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 |
|---|---|---|
| Arbaclofen placarbil 15 mg BIDAlso: XP19986 SR4arbaclofen placarbil 15 mg BID | Drug | Arbaclofen placarbil 15 mg BID |
| PlaceboAlso: Sugar PillPlacebo for arbaclofen placarbil 15, 30 and 45 mg BID | Drug | Placebo |
| Arbaclofen placarbil 30 mg BIDAlso: XP19986 SR4arbaclofen placarbil 30 mg BID | Drug | Arbaclofen placarbil 30 mg BID |
| Arbaclofen placarbil 45 mg BIDAlso: XP19986 SR4arbaclofen placarbil 45 mg BID | Drug | Arbaclofen placarbil 45 mg BID |
Primary outcome
Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)
Time frame: 10-weeks
numerical score
Patient Global Impression of Change (PGIC) score
Time frame: 10-weeks
numerical score
3 secondary outcomes
Change in the overall Modified PRISM score
Time frame: Weeks 4, 6, 10
Change in weekly average severity of pain score associated with muscle spasm.
Time frame: Week 10
Change in weekly average VAS score of sleep quality
Time frame: Week 10
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 21 Feb 2021.
- The Command Clinical Research Trial WebsiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Study Director study director
Indivior Inc.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arbaclofen placarbil 15 mg BID, Arbaclofen placarbil 30 mg BID and Arbaclofen placarbil 45 mg BID in people with Multiple Sclerosis, run by XenoPort, Inc. at 28 sites in United States.
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 6 inclusion and 10 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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?
Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point) (time frame: 10-weeks). 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 21 Feb 2021.