A PHASE 3, 40-WEEK, ACTIVE-CONTROLLED, DOUBLE-BLIND EXTENSION STUDY OF PRELADENANT IN SUBJECTS WITH MODERATE TO SEVERE PARKINSON´S DISEASE (PHASE 3, PROTOCOL N° P06153)

Not Applicable

• Registration Number: PER-038-11
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

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

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%).

Study & Design

• Study Type: Interventional
• Study Design: Not specified