None listed
Conditions
Interventions
FOR THE ENTIRE DURATION OF THE TRIAL, INCLUDING DURING STUDY VISITS, SUBJECTS WILL CONTINUE TO TAKE THEIR L-DOPA AND ADJUNCT PD MEDICATIONS AS PRESCRIBED.
ALL SUBJECTS WHO HAVE COMPLETED THE DOUBLE
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Age
30 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. SUBJECTS MUST HAVE COMPLETED P04938 OR PO7037 2. EACH SUBJECT (OR SUBJECT´S LEGAL REPRESENTATIVE) MUST BE WILLING AND ABLE TO PROVIDE WRITTEN INFORMED CONSENT FOR THE P06153. FOR A SUBJECT WHO IS UNABLE TO PROVIDE INDEPENDENT CONSENT, A LEGAL REPRESENTATIVE MAY PROVIDE WRITTEN INFORMED CONSENT. 3. SUBJECTS MUST BE ABLE TO ADHERE TO DOSE AND VISIT SCHEDULES. 4. SUBJECTS MUST BE TAKING LEVODOPA (L-DOPA). 5. SUBJECTS MAY BE TAKING ANY OF THE ADDITIONAL ADJUNCT PD MEDICATIONS SHOWN IN TABLE 1. NOTE: SUBJECTS TAKING ONLY L-DOPA ARE PERMITTED TO ENROLL IN THIS TRIAL IF THEY MEET THE PREVIOUS INCLUSION CRITRION.
Exclusion criteria
Exclusion criteria: 1. A SUBJECT MUST NOT HAVE DISCONTINUED FROM PO4938 OR P07037 FOR ANY REASON. 2. A SUBJECT MUST NOT HAVE A SEVERE OR ONGOING UNSTABLE MEDICAL CONDITION (eg, ANY FORM OF CLINICALLY SIGNIFICANT CARDIAC DISEASE, SYMPTOMATIC ORTHOSTATIC HYPOTENSION, SEIZURES OR ALCOHOL/DRUG DEPENDENCE). 3. A SUBJECT MUST NOT HAVE POORLY CONTROLLED DIABETES (eg, HbA1c> 8.5) OR SIGNIFICANTLY ABNORMAL RENAL FUNCTION (eg, CREATININE> 2.0 MG/DL) IN THE OPINION OF THE INVESTIGATOR. 4. AS A CONTlNUED OF THE LIVER-RELATED WITHDRAWAL CRITERIA FROM THE PARENT STUDIES (P04938 AND P07037), ANY SUBJECT WITH ELEVATED VALUES FOR ALANINE AMINOTRANSFERASE (ALT), ASPARTATE AMINOTRANSFERASE (AST), OR TOTAL BILIRUBIN (T-BIL), AS EVIDENCED BY THE MOST RECENT CHEMISTRY PANEL RESULTSIN THE PARENT STUDY, MEETING ANY ONE OF THE FOLLOWING CRITERIA: A) ALT OR AST> 8 X ULN. B) ALT OR AST> 5 X ULN FOR MORE THAN 2 WEEKS. C) ALT OR AST> 3 x ULN AND (T-BIL> 2 x ULN OR INTERNATIONAL NORMALIZED RATIO [INR]> 1.5) AT THE SAME VISIT. D) ALT OR AST> 3 x ULN WITH THE APPEARANCE OF WORSENING FATIGUE, NAUSEA, VOMITING, RIGHT UPPER QUADRANT PAIN OR TENDERNESS, FEVER, RASH AND/OR EOSINOPHILIA (> 5%).
Countries
Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Finland, France, India, Israel, Italy, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed