Parkinson's DiseasePhase 4NCT00601978
Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off
A Phase 4 study testing carbidopa/levodopa and Carbidopa/Levodopa/Entacapone in people with Parkinson's Disease, run by Novartis Pharmaceuticals.
Trial summary
This study will evaluate the effects of immediate release (IR) carbidopa levodopa versus the effects of immediate-release carbidopa/levodopa on ERP parameters in patients with idiopathic PD. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- carbidopa/levodopa and Carbidopa/Levodopa/Entacapone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Nov 2009
- Phase
- Phase 4
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 45 to 75 years (inclusive)
- Patients with an MMSE score of at least 25 at the screening visit.
- Patients who experience EODWO, which is the re-emergence of PD symptoms during the waking hours, as determined by a WOQ-9 score of at least one motor symptom of wearing off
- Patients taking a stable dose of immediate-release carbidopa/levodopa for at least 4 weeks prior to randomization, at an equivalent total daily dose of levodopa between 300 to 600 mg/day.
- Patients who, in the investigator's judgement, are capable of satisfying the requirements of the protocol
- Patients who are willing and able to give written informed consent according to legal requirements.
Who cannot join
- Diagnosis of secondary parkinsonism, atypical Parkinson's disease, or history, signs, or symptoms suggesting these diagnoses.
- Unstable Parkinson's disease as determined by the investigator.
- Disabling dyskinesia (a score of >2 on the Unified Parkinson's Disease Rating Scale [UPDRS] question #32, or a score of >2 on UPDRS question #33).
- Treatment with carbidopa/levodopa controlled-release or extended-release formulations (bedtime administration is acceptable). The use of controlled-release carbidopa/levodopa is not allowed on the evening before the visits in which efficacy assessments occur.
- Concomitant or previous treatment with certain medications or supplements as specified in the protocol.
- Patients who are unable to comply with the dosing requirements of the protocol, such that the first dose of study medication will be taken after the time of the first EEG and the second dose will be taken after completion of the third EEG.
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- Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR; diagnosis of 1. dementia (of any cause); 2. moderate or severe major depression, present independent from the time of first diagnosis of PD, as defined by a QIDS-SR16 score of > 15; or 3. generalized anxiety disorder or panic disorder if made prior to the diagnosis of PD.
- DSM-IV-TR diagnosis of alcohol or substance abuse (excluding nicotine or caffeine) during the 3 months prior to randomization) or alcohol or substance dependence (excluding nicotine or caffeine) during the 6 months prior to randomization. Alcohol should be avoided within the 12 hours preceding the Week 6 and Week 12 visits.
- Nicotine use of >5 cigarettes (or equivalent in other forms of administration) per day. Nicotine use will not be permitted on the day of the Week 6 and Week 12 visits.
- Ingestion of >4 caffeinated beverages (or equivalent in other forms of administration) per day.
- History of major head injury, including skull fracture or a penetrating head injury, or a history of brain surgery.
- Past or current treatment by deep brain stimulation.
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- Hearing loss or impairment that may prevent reliability of test results using auditory evoked potentials.
About this study
Official title: A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off
This study will evaluate the effects of immediate release (IR) carbidopa levodopa versus the effects of immediate-release carbidopa/levodopa on ERP parameters in patients with idiopathic PD.
- Conditions
- Parkinson's Disease
- Being tested
- carbidopa/levodopa, Carbidopa/Levodopa/Entacapone
- Keywords
- Parkinson's disease, carbidopa/levodopa/entacapone, carbidopa/levodopa, non-motor symptoms, event-related potential, ERP, EEG, electroencephalogram
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbidopa/levodopaDrug
Carbidopa/Levodopa/EntacaponeDrug
Also called Stalevo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Immediate-Release Carbidopa/Levodopa Receives: Drug: carbidopa/levodopa |
| 2 | Active comparator | Carbidopa/Levodopa/Entacapone Receives: Drug: Carbidopa/Levodopa/Entacapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration
Secondary outcomes (3)
Mean latency of the P300 component of ERPs at pre-dose and 1 hours post-dose study drug administration
Mean latency of the N100 component of ERPs at pre-dose, 1 hour post-dose and 4 hours post-dose study drug administration
Pharmacokinetics at 9.25 and 12.55 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Business decision brand strategy; no patients enrolled
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.
- More trials run by Novartis PharmaceuticalsThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601978
- Sponsor's protocol ID
- CELC200AUS15
- Status last verified
- Apr 2012
- First submitted
- 11 Jan 2008
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off
- ClinicalTrials.gov ID
- NCT00601978
- Acronym / sponsor ID
- CELC200AUS15
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, carbidopa/levodopa/entacapone, carbidopa/levodopa, non-motor symptoms, event-related potential, ERP, EEG, electroencephalogram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision brand strategy; no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Jan 2008 (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.
This study will evaluate the effects of immediate release (IR) carbidopa levodopa versus the effects of immediate-release carbidopa/levodopa on ERP parameters in patients with idiopathic PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: carbidopa/levodopaImmediate-Release Carbidopa/Levodopa |
| 2 | Active comparator | Drug: Carbidopa/Levodopa/EntacaponeCarbidopa/Levodopa/Entacapone |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 45 to 75 years (inclusive)
- Patients with an MMSE score of at least 25 at the screening visit.
- Patients who experience EODWO, which is the re-emergence of PD symptoms during the waking hours, as determined by a WOQ-9 score of at least one motor symptom of wearing off
- Patients taking a stable dose of immediate-release carbidopa/levodopa for at least 4 weeks prior to randomization, at an equivalent total daily dose of levodopa between 300 to 600 mg/day.
- Patients who, in the investigator's judgement, are capable of satisfying the requirements of the protocol
Key exclusion criteria (14 listed)
- Diagnosis of secondary parkinsonism, atypical Parkinson's disease, or history, signs, or symptoms suggesting these diagnoses.
- Unstable Parkinson's disease as determined by the investigator.
- Disabling dyskinesia (a score of >2 on the Unified Parkinson's Disease Rating Scale [UPDRS] question #32, or a score of >2 on UPDRS question #33).
- Treatment with carbidopa/levodopa controlled-release or extended-release formulations (bedtime administration is acceptable). The use of controlled-release carbidopa/levodopa is not allowed on the evening before the visits in which efficacy assessments occur.
- Concomitant or previous treatment with certain medications or supplements as specified in the protocol.
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 |
|---|---|---|
| carbidopa/levodopa | Drug | 1 |
| Carbidopa/Levodopa/EntacaponeAlso: Stalevo | Drug | 2 |
Primary outcome
To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration
3 secondary outcomes
Mean latency of the P300 component of ERPs at pre-dose and 1 hours post-dose study drug administration
Mean latency of the N100 component of ERPs at pre-dose, 1 hour post-dose and 4 hours post-dose study drug administration
Pharmacokinetics at 9.25 and 12.55 hours post dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carbidopa/levodopa and Carbidopa/Levodopa/Entacapone in people with Parkinson's Disease, run by Novartis Pharmaceuticals.
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 14 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: withdrawn, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration. 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 30 Apr 2012.