Parkinson's DiseasePhase 2NCT01171313
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
A Phase 2 study testing XP21279 and carbidopa (experimental) and Sinemet (comparator) in people with Parkinson's Disease, run by XenoPort, Inc. at 12 sites in United States.
Trial summary
The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- XP21279 and carbidopa (experimental) and Sinemet (comparator)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2010to Dec 2011
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the Screening Period:
- Wearing-off in at least half (50%) of inter-dose intervals between the first and the last daily doses averaged over the 3 diary days, and
- An average daily "off" time of 2 hours after the first "on" of the day through awake time up to midnight.
- Subjects must be on one of the following stable QID or 5 times daily regimens for at least 4 weeks prior to Screening: Sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa
Who cannot join
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
- Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
- Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
XenoPort Clinical Site
Bingham Farms, Michigan, 48025
XenoPort Clinical Site
Houston, Texas, 77030
XenoPort Clinical Site
Kansas City, Kansas, 66160
XenoPort Clinical Site
Little Rock, Arkansas, 72205
XenoPort Clinical Site
Long Beach, California, 90806
XenoPort Clinical Site
Naples, Florida, 34102
XenoPort Clinical Site
New Brunswick, New Jersey, 08901
XenoPort Clinical Site
Phoenix, Arizona, 85013
XenoPort Clinical Site
Sunnyvale, California, 94085
XenoPort Clinical Site
Tampa, Florida, 33606
XenoPort Clinical Site
Tulsa, Oklahoma, 74137
XenoPort Clinical Site
West Bloomfield, Michigan, 48322-3013
About this study
Official title: A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.
- Conditions
- Parkinson's Disease
- Being tested
- XP21279 and carbidopa (experimental), Sinemet (comparator), Placebo for XP21279 and carbidopa, Placebo for Sinemet
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP21279 and carbidopa (experimental)Drug
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Sinemet (comparator)Drug
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Placebo for XP21279 and carbidopaDrug
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
Placebo for SinemetDrug
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. Receives: Drug: XP21279 and carbidopa (experimental); Drug: Sinemet (comparator); Drug: Placebo for XP21279 and carbidopa; Drug: Placebo for Sinemet |
| Treatment sequence 2 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. Receives: Drug: XP21279 and carbidopa (experimental); Drug: Sinemet (comparator); Drug: Placebo for XP21279 and carbidopa; Drug: Placebo for Sinemet |
| Treatment sequence 3 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. Receives: Drug: XP21279 and carbidopa (experimental); Drug: Sinemet (comparator); Drug: Placebo for XP21279 and carbidopa; Drug: Placebo for Sinemet |
| Treatment sequence 4 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. Receives: Drug: XP21279 and carbidopa (experimental); Drug: Sinemet (comparator); Drug: Placebo for XP21279 and carbidopa; Drug: Placebo for Sinemet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
Measured: 2 weeks
Secondary outcomes (1)
Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Chen, M.D., Study director, XenoPort, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171313
- Sponsor's protocol ID
- XP-C-069
- Other IDs
- XenoPort
- Status last verified
- Feb 2021
- First submitted
- 26 Jul 2010
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
- ClinicalTrials.gov ID
- NCT01171313
- Acronym / sponsor ID
- XP-C-069
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jul 2010 (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 the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Drug: XP21279 and carbidopa (experimental), Drug: Sinemet (comparator), Drug: Placebo for XP21279 and carbidopa, Drug: Placebo for SinemetSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
| Treatment sequence 2 | Experimental | Drug: XP21279 and carbidopa (experimental), Drug: Sinemet (comparator), Drug: Placebo for XP21279 and carbidopa, Drug: Placebo for SinemetSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
| Treatment sequence 3 | Experimental | Drug: XP21279 and carbidopa (experimental), Drug: Sinemet (comparator), Drug: Placebo for XP21279 and carbidopa, Drug: Placebo for SinemetSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
| Treatment sequence 4 | Experimental | Drug: XP21279 and carbidopa (experimental), Drug: Sinemet (comparator), Drug: Placebo for XP21279 and carbidopa, Drug: Placebo for SinemetSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the Screening Period:
- Subjects must be on one of the following stable QID or 5 times daily regimens for at least 4 weeks prior to Screening: Sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa
Key exclusion criteria (4 listed)
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
- Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
- Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
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 |
|---|---|---|
| XP21279 and carbidopa (experimental)Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4 |
| Sinemet (comparator)Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet. | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4 |
| Placebo for XP21279 and carbidopaEligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4 |
| Placebo for SinemetEligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4 |
Primary outcome
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
Time frame: 2 weeks
1 secondary outcome
Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods
Time frame: 2 weeks
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 18 Feb 2021.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Dan Chen, M.D. study director
XenoPort, Inc.
12 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 XP21279 and carbidopa (experimental) and Sinemet (comparator) in people with Parkinson's Disease, run by XenoPort, Inc. at 12 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 4 inclusion and 4 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 18 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 12 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?
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods. (time frame: 2 weeks). 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 18 Feb 2021.