Muscle SpasticityPhase 2NCT00557973
A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
A Phase 2 study testing XP19986 SR1, 10 mg BID, XP19986 SR1, 20 mg BID and XP19986 SR1, 30 mg BID in people with Muscle Spasticity, run by XenoPort, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- XP19986 SR1, 10 mg BID, XP19986 SR1, 20 mg BID and XP19986 SR1, 30 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2007to Apr 2009
- Phase
- Phase 2
- 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
- Spasticity secondary to traumatic spinal cord injury between C-5 and T-12 spinal cord levels, at least 12 months post-injury with a stable neurological deficit
Who cannot join
- Traumatic brain injury or cognitive deficit of any etiology that may influence compliance with study procedures or outcome measures
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Chicago, Illinois
Study site
Detroit, Michigan
Study site
Downey, California
Study site
Englewood, Colorado
Study site
Gilroy, California
Study site
Kansas City, Kansas
Study site
Miami, Florida
Study site
Pasadena, California
Study site
San Jose, California
About this study
Official title: Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury
Read the detailed description
This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment. Each subject serves as their own control in this cross-over study.
- Conditions
- Muscle Spasticity
- Being tested
- XP19986 SR1, 10 mg BID, XP19986 SR1, 20 mg BID, XP19986 SR1, 30 mg BID, 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.
XP19986 SR1, 10 mg BIDDrug
Also called Sustained release Polyox WSR N750, 10 mg
XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
XP19986 SR1, 20 mg BIDDrug
Also called Sustained release Polyox WSR N750, 20 mg
XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
XP19986 SR1, 30 mg BIDDrug
Also called Sustained release Polyox WSR N750, 30 mg
XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
PlaceboDrug
Also called sugar pill
Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.
| Study group | Role | What they receive |
|---|---|---|
| XP19986 SR1 10 mg - Placebo | Experimental | Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout. Receives: Drug: XP19986 SR1, 10 mg BID; Drug: Placebo |
| XP19986 SR1 20 mg - Placebo | Experimental | Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout. Receives: Drug: XP19986 SR1, 20 mg BID; Drug: Placebo |
| XP19986 SR1 30 mg - Placebo | Experimental | Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout. Receives: Drug: XP19986 SR1, 30 mg BID; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Ashworth score
Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose. Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment
Measured: Day 17
Secondary outcomes (3)
Average Ashworth score
This was the average of Ashworth scores obtained on Day 17 of dosing across 6 muscle groups for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
Measured: Day 17
Two Highest Ashworth scores
This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had the 2 highest Ashworth scores at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
Measured: Day 17
Average Non-zero Ashworth Scores
This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had a non-zero Ashworth score at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
Measured: Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Leong, M.D., Study director, XenoPort, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557973
- Sponsor's protocol ID
- XP-B-065
- Status last verified
- Feb 2021
- First submitted
- 12 Nov 2007
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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
- Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00557973
- Acronym / sponsor ID
- XP-B-065
- Conditions
- Muscle Spasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Nov 2007 (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.
The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury
Detailed description
This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment. Each subject serves as their own control in this cross-over study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XP19986 SR1 10 mg - Placebo | Experimental | Drug: XP19986 SR1, 10 mg BID, Drug: PlaceboFollowing a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout. |
| XP19986 SR1 20 mg - Placebo | Experimental | Drug: XP19986 SR1, 20 mg BID, Drug: PlaceboFollowing a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout. |
| XP19986 SR1 30 mg - Placebo | Experimental | Drug: XP19986 SR1, 30 mg BID, Drug: PlaceboFollowing a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Spasticity secondary to traumatic spinal cord injury between C-5 and T-12 spinal cord levels, at least 12 months post-injury with a stable neurological deficit
Key exclusion criteria (1 listed)
- Traumatic brain injury or cognitive deficit of any etiology that may influence compliance with study procedures or outcome measures
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 |
|---|---|---|
| XP19986 SR1, 10 mg BIDAlso: Sustained release Polyox WSR N750, 10 mgXP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods | Drug | XP19986 SR1 10 mg - Placebo |
| XP19986 SR1, 20 mg BIDAlso: Sustained release Polyox WSR N750, 20 mgXP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods | Drug | XP19986 SR1 20 mg - Placebo |
| XP19986 SR1, 30 mg BIDAlso: Sustained release Polyox WSR N750, 30 mgXP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods | Drug | XP19986 SR1 30 mg - Placebo |
| PlaceboAlso: sugar pillPlacebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods. | Drug | XP19986 SR1 10 mg - Placebo, XP19986 SR1 20 mg - Placebo, XP19986 SR1 30 mg - Placebo |
Primary outcome
Maximum Ashworth score
Time frame: Day 17
Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose. Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment
3 secondary outcomes
Average Ashworth score
Time frame: Day 17
Two Highest Ashworth scores
Time frame: Day 17
Average Non-zero Ashworth Scores
Time frame: Day 17
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.
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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.
Michael Leong, M.D. study director
XenoPort, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XP19986 SR1, 10 mg BID, XP19986 SR1, 20 mg BID and XP19986 SR1, 30 mg BID in people with Muscle Spasticity, run by XenoPort, Inc. at 11 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 1 inclusion and 1 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 11 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Maximum Ashworth score (time frame: Day 17). 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.