Parkinson's DiseasePhase 1/2NCT00914602
An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects
A Phase 1/2 study testing Sinemet 25-100 Oral Tablet, XP21279 and Carbidopa Pill in people with Parkinson's Disease, run by XenoPort, Inc. at 2 sites in United States.
Trial summary
The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Sinemet 25-100 Oral Tablet, XP21279 and Carbidopa Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Jan 2010
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a clinical diagnosis of idiopathic Parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity).
- Subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (Days -4 to -2) in the Screening Period.
- Subjects must be on stable TID or QID Sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to Screening.
Who cannot join
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- Subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the UPDRS at Screening.
- Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.
- Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.
- Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
XenoPort Investigational Site
Bingham Farms, Michigan, 48025
XenoPort Investigational Site
Peoria, Arizona, 85381
About this study
Official title: An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.
Read the detailed description
This is a Phase 1/Phase 2 multiple-dose, multi-center, open-label, two period sequential-treatment study in subjects with Parkinson's disease to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease and to explore dose correspondence between XP21279 and Sinemet® to guide dose selection for future studies in the target population (subjects with Parkinson's disease with motor fluctuations on Sinemet®).
- Conditions
- Parkinson's Disease
- Being tested
- Sinemet 25-100 Oral Tablet, XP21279, Carbidopa Pill
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinemet 25-100 Oral TabletDrug
Also called Carbidopa / Levodopa
After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.
XP21279Drug
Also called XP21279 sustained related
Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).
Carbidopa PillDrug
Also called Lodosyn
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period A | Active comparator | Treatment Period A: Sinemet® 25-100 treatment After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days. Receives: Drug: Sinemet 25-100 Oral Tablet |
| Treatment Period B | Experimental | Multiple-Dose XP21279 (with Lodosyn®) treatment. Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®). Receives: Drug: XP21279; Drug: Carbidopa Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the pharmacokinetics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.
To establish a pharmacokinetic profile for XP21279
Measured: 4 weeks
to assess the Pharmacodynamics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.
Changes in The Brief Parkinsonism Rating Scale during treatment
Measured: 4 weeks
to assess the safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.
Observe values and changes in clinical laboratory and vital sign parameters describe by time of collection for each treatment period.
Measured: 4 weeks
Secondary outcomes (1)
the dose correspondence between XP21279 and Sinemet® will be explored to guide dose selection for future studies in the target population
comparison of PK levels and doses.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve D Caras, MD, Study chair, Arbor Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914602
- Sponsor's protocol ID
- XP-C-058
- Status last verified
- Apr 2021
- First submitted
- 3 Jun 2009
- Last updated
- 5 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
- ClinicalTrials.gov ID
- NCT00914602
- Acronym / sponsor ID
- XP-C-058
- Conditions
- Parkinson's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Jun 2009 (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 pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.
Detailed description
This is a Phase 1/Phase 2 multiple-dose, multi-center, open-label, two period sequential-treatment study in subjects with Parkinson's disease to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease and to explore dose correspondence between XP21279 and Sinemet® to guide dose selection for future studies in the target population (subjects with Parkinson's disease with motor fluctuations on Sinemet®).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Period A | Active comparator | Drug: Sinemet 25-100 Oral TabletTreatment Period A: Sinemet® 25-100 treatment After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days. |
| Treatment Period B | Experimental | Drug: XP21279, Drug: Carbidopa PillMultiple-Dose XP21279 (with Lodosyn®) treatment. Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®). |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with a clinical diagnosis of idiopathic Parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity).
- Subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (Days -4 to -2) in the Screening Period.
- Subjects must be on stable TID or QID Sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to Screening.
Key exclusion criteria (5 listed)
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- Subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the UPDRS at Screening.
- Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.
- Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.
- Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).
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 |
|---|---|---|
| Sinemet 25-100 Oral TabletAlso: Carbidopa / LevodopaAfter screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days. | Drug | Treatment Period A |
| XP21279Also: XP21279 sustained relatedUpon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®). | Drug | Treatment Period B |
| Carbidopa PillAlso: Lodosyn | Drug | Treatment Period B |
Primary outcome
to assess the pharmacokinetics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.
Time frame: 4 weeks
To establish a pharmacokinetic profile for XP21279
to assess the Pharmacodynamics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.
Time frame: 4 weeks
Changes in The Brief Parkinsonism Rating Scale during treatment
to assess the safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.
Time frame: 4 weeks
Observe values and changes in clinical laboratory and vital sign parameters describe by time of collection for each treatment period.
1 secondary outcome
the dose correspondence between XP21279 and Sinemet® will be explored to guide dose selection for future studies in the target population
Time frame: 4 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 5 May 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.
Steve D Caras, MD study chair
Arbor Pharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sinemet 25-100 Oral Tablet, XP21279 and Carbidopa Pill in people with Parkinson's Disease, run by XenoPort, Inc. at 2 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 3 inclusion and 5 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
to assess the pharmacokinetics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease. (time frame: 4 weeks). The study lists 3 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 5 May 2021.