Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing Off
This study is ongoing, but not recruiting participants.
Study NCT00391898   Information provided by Novartis
First Received: October 24, 2006   Last Updated: June 6, 2008   History of Changes

October 24, 2006
June 6, 2008
October 2006
 
Unified Parkinson Disease Rating Scale score, Part II (Activities of daily living) at the beginning of the study and at 3 months
Same as current
Complete list of historical versions of study NCT00391898 on ClinicalTrials.gov Archive Site
  • Unified Parkinson Disease Rating Scale scores parts I (Mentation, behavior and mood), III (Motor examination), IV (Complications of the treatment) and total score at the beginning of the study and at 3 months
  • Parkinson Disease Questionnaire-39 items at the beginning of the study and at 3 months
  • Global assessments of the treatment, by patient and investigator, at baseline and 3 months
Same as current
 
Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing Off
A 3-Month, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing Off With Levodopa

The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa

The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Parkinson's Disease
Drug: Levodopa/carbidopa/entacapona
  • Experimental: Levodopa/carbidopa/entacapone
  • Active Comparator: Levodopa/carbidopa
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
June 2008
 

Inclusion Criteria:

  1. Male and female patients ages ≥ 30 and ≤ 80 years old.
  2. A clinical diagnosis of idiopathic Parkinson's disease.
  3. Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
  4. Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day

    • 1 full tablet, and/or
    • 1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
  5. Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
  6. Must have a minimum UPDRS part II (ADL) score of 9.
  7. Patients without dyskinesia or with mild dyskinesia.
  8. Female patients must be either post-menopausal or using one or more acceptable methods of contraception
  9. Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements

Exclusion Criteria:

  1. Previous or current use of entacapone.
  2. History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
  3. Unstable Parkinson's disease patients
  4. Patients who experience severe dyskinesia
  5. The following levodopa/carbidopa doses and strengths are not permitted:

    • Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
    • Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
    • Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
  6. Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
  7. Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
  8. Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit
  9. Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis
  10. Participated in another trial of an investigational drug/device within the last 30 days prior to study entry
  11. Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements
Both
30 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00391898
External Affairs, Novartis Pharmaceuticals
CELC200AES03
Novartis
 
Principal Investigator: Eduard Tolosa-Sarró, Dr. Hospital Clínic i Provincial de Barcelona
Novartis
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP