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

This study has been withdrawn prior to enrollment.
(Business decision brand strategy; no patients enrolled)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00601978
First received: January 11, 2008
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: carbidopa/levodopa
Drug: Carbidopa/Levodopa/Entacapone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration

Secondary Outcome Measures:
  • 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

Enrollment: 0
Study Start Date: August 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Immediate-Release Carbidopa/Levodopa
Drug: carbidopa/levodopa
Active Comparator: 2
Carbidopa/Levodopa/Entacapone
Drug: Carbidopa/Levodopa/Entacapone
Other Name: Stalevo

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00601978     History of Changes
Other Study ID Numbers: CELC200AUS15
Study First Received: January 11, 2008
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Parkinson's disease
carbidopa/levodopa/entacapone
carbidopa/levodopa
non-motor symptoms
event-related potential
ERP
EEG
electroencephalogram

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Entacapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014