Parkinson's DiseasePhase 4NCT00590122
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
A Phase 4 study testing Parcopa and carbidopa-levodopa (Sinemet) in people with Parkinson's Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients. Read more about this study
- Who is it for?
- Ages 31 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Parcopa and carbidopa-levodopa (Sinemet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 31 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration
- Patients requiring levodopa for their PD
- Good subjective response to levodopa
- Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
- A UPDRS -off- motor score of at least 25
- Subjects willing to give informed consent
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- Subjects who are able and willing to comply with study procedures
- If female of child-bearing potential, will use one of the approved birth control measures:
- Hormonal contraceptives
- Spermicidal and barrier
- Intrauterine device
- Partner sterility
Who cannot join
- Subjects with evidence of significant dementia
- Subjects with significant oral lesions
- History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
- History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
- History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
- Subjects with poor response to levodopa
- Women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.
Trial locations and contacts
1 site in 1 country.
United States1 site
PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, 77030
About this study
Official title: Comparison of Orally Dissolving Carbidopa/Levodopa (Parcopa) to Conventional Oral Carbidopa/Levodopa: A Single-Dose, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Trial
To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
Read the detailed description
This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.
- Conditions
- Parkinson's Disease
- Being tested
- Parcopa, carbidopa-levodopa (Sinemet)
- Keywords
- Parkinson's disease, time to "on", delayed on
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParcopaDrug
at subjects current stable dose of comparator
carbidopa-levodopa (Sinemet)Drug
at subjects current stable dose
| Study group | Role | What they receive |
|---|---|---|
| Randomization Group b | Experimental | Parcopa at equivalent dosage to subjects current stable dose Receives: Drug: Parcopa |
| Randomization Group a | Active comparator | Carbidopa-levodopa (Sinemet)at subjects current stable dose Receives: Drug: carbidopa-levodopa (Sinemet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State
Time to "on" state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.
Measured: first dose of day for each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2006
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, Joseph Jankovic, Baylor College of Medicine
- Investigators
- William G Ondo, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590122
- Sponsor's protocol ID
- H-19596
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2007
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ondo WG, Shinawi L, Moore S. Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. Mov Disord. 2010 Dec 15;25(16):2724-7. doi: 10.1002/mds.23158.
PubMed 20925074
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Orally Dissolving Carbidopa/Levodopa (Parcopa) to Conventional Oral Carbidopa/Levodopa: A Single-Dose, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT00590122
- Acronym / sponsor ID
- H-19596
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, time to "on", delayed on
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Oct 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
Detailed description
This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomization Group b | Experimental | Drug: ParcopaParcopa at equivalent dosage to subjects current stable dose |
| Randomization Group a | Active comparator | Drug: carbidopa-levodopa (Sinemet)Carbidopa-levodopa (Sinemet)at subjects current stable dose |
Who may qualify
- Ages
- 31 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration
- Patients requiring levodopa for their PD
- Good subjective response to levodopa
- Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
- A UPDRS -off- motor score of at least 25
Key exclusion criteria (7 listed)
- Subjects with evidence of significant dementia
- Subjects with significant oral lesions
- History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
- History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
- History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
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 |
|---|---|---|
| Parcopaat subjects current stable dose of comparator | Drug | Randomization Group b |
| carbidopa-levodopa (Sinemet)at subjects current stable dose | Drug | Randomization Group a |
Primary outcome
Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State
Time frame: first dose of day for each arm
Time to "on" state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20925074Ondo WG, Shinawi L, Moore S. Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. Mov Disord. 2010 Dec 15;25(16):2724-7. doi: 10.1002/mds.23158.
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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.
William G Ondo, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Parcopa and carbidopa-levodopa (Sinemet) in people with Parkinson's Disease, run by Baylor College of Medicine at 1 site 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 12 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: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State (time frame: first dose of day for each arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590122, which also lists 1 linked publication.
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 14 Mar 2023.