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WithdrawnNCT00601978Updated Apr 30, 2012

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 interventional study of carbidopa/levodopa and Carbidopa/Levodopa/Entacapone in Parkinson's Disease, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-04-30.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Business decision brand strategy; no patients enrolled
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • Parkinson's disease
  • carbidopa/levodopa/entacapone
  • carbidopa/levodopa
  • non-motor symptoms
  • event-related potential
  • ERP
  • EEG
  • electroencephalogram
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

Browse Parkinson Disease studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female patients aged 45 to 75 years (inclusive)
  2. Patients with an MMSE score of at least 25 at the screening visit.
  3. 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
  4. 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.
  5. Patients who, in the investigator's judgement, are capable of satisfying the requirements of the protocol
  6. Patients who are willing and able to give written informed consent according to legal requirements.

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of secondary parkinsonism, atypical Parkinson's disease, or history, signs, or symptoms suggesting these diagnoses.
  2. Unstable Parkinson's disease as determined by the investigator.
  3. 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).
  4. 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.
  5. Concomitant or previous treatment with certain medications or supplements as specified in the protocol.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Ingestion of >4 caffeinated beverages (or equivalent in other forms of administration) per day.
  11. History of major head injury, including skull fracture or a penetrating head injury, or a history of brain surgery.
  12. Past or current treatment by deep brain stimulation.
  13. 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.
  14. Hearing loss or impairment that may prevent reliability of test results using auditory evoked potentials.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    1

    Immediate-Release Carbidopa/Levodopa

    Drug: carbidopa/levodopa

  • Active comparator
    2

    Carbidopa/Levodopa/Entacapone

    Drug: Carbidopa/Levodopa/Entacapone

Interventions

  • Drugcarbidopa/levodopa
  • DrugCarbidopa/Levodopa/Entacapone

    Also known as: Stalevo

06

What researchers measure

Primary outcomes

  1. To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration

Secondary outcomes

  1. Mean latency of the P300 component of ERPs at pre-dose and 1 hours post-dose study drug administration

  2. Mean latency of the N100 component of ERPs at pre-dose, 1 hour post-dose and 4 hours post-dose study drug administration

  3. Pharmacokinetics at 9.25 and 12.55 hours post dose

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00601978
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 28, 2008
Start date
Aug 2008
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Apr 30, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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