| CTRI Number |
CTRI/2012/07/002811 [Registered on: 19/07/2012] Trial Registered Prospectively |
| Last Modified On: |
11/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Active-Controlled Extension Study to P04938 and P07037 (Study P06153 AM3) |
|
Scientific Title of Study
|
A Phase 3, 40‑Week, Active‑Controlled, Double‑Blind, Double‑Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinsons Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT01215227 |
ClinicalTrials.gov |
| P06153, Version 1; dated 5 Nov 2010 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Monisha Sharma |
| Designation |
Director- Clinical Research, India |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd. |
| Address |
6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon HARYANA 122002 India
Gurgaon
HARYANA
122002
India |
| Phone |
91-124-4647300 |
| Fax |
91-124-4375561 |
| Email |
monisha_sharma@merck.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Monisha Sharma |
| Designation |
Director- Clinical Research, India |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd. |
| Address |
6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon HARYANA 122002 India
Gurgaon
HARYANA
122002
India |
| Phone |
91-124-4647300 |
| Fax |
91-124-4375561 |
| Email |
monisha_sharma@merck.com |
|
|
Source of Monetary or Material Support
|
| Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc.
(hereafter referred to as
the SPONSOR or Merck)
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100, U.S.A |
|
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Primary Sponsor
|
| Name |
Merck Sharp Dohme |
| Address |
One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Fulford India Limited |
Fulford (India) Limited,
8th Floor, Platina Plot No. C-59, G-Block Bandra-Kurla Complex, Bandra (E), Mumbai 400098 |
|
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Countries of Recruitment
|
Argentina
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Finland
France
Germany
India
Ireland
Israel
Italy
Latvia
Lithuania
Mexico
Netherlands
New Zealand
Peru
Poland
Portugal
Russian Federation
Serbia
South Africa
Spain
Sweden
Turkey
Ukraine
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohit Bhatt |
Kokilaben Dhirubhai Ambani Hosp.& Med. Research Institute |
Medical Research Department,Room No. 19,15th Floor,Kokilaben Dhirubhai Ambani Hosp.& Med. Research Inst.
Rao Saheb Achutrao Patwardhan Marg
Four Bunglows, Andheri West
400053
Mumbai (Suburban)
MAHARASHTRA |
91-22-30666666
drmbhatt@gmail.com |
| Dr Angamuthu Meena |
Nizam Institute of Medical Sciences |
Department of Neurology,Room No. 329/A,3rd floor,
Nizams Institute of Medical Sciences
Panjagutta
500082
Hyderabad
ANDHRA PRADESH |
91-40-23320332
meenaak@hotmail.com |
| Dr Charulata Sankhla |
P.D.Hinduja National Hospital & Medical Research Centre |
Neurology Department, Room No. 2107, 2nd Floor,
P.D. Hinduja Nat. Hospital & Med. Research Centre
Veer Savarkar Marg
400163
Mumbai
MAHARASHTRA |
91-22-24447179
charusankhla@gmail.com |
| Dr Uday Muthane |
Parkinson’s & Ageing Research Foundation |
Room No. 6 (Drug Trial Room,2nd Floor,
Parkinsons and Aging Research Foundation
Panjagutta
500082
Hyderabad
ANDHRA PRADESH |
91-80-25599190
umuthane@usa.net |
| Dr Asha Kishore |
Sree Chitra Tirunal Institute for Medical Sciences & Technology |
Neuro Pharmacology Women Disorder Section,
Basement,Sree Chitra Tirunal Institute for Medical Sciences & Technology
SCTIMST P. O.
695011
Thiruvananthapuram
KERALA |
91-471-2524400
ashakishore99@gmail.com |
| Dr Sarma |
St. Johns Medical College Hospital |
Department of Neurology, 3rd Floor,
Sarjapur Road
Koramangala
Bangalore, 560034, KARNA
Bangalore
KARNATAKA |
080-22065780
grk_sarma@yahoo.com |
| Dr Suresh Kumar |
Vijaya Health Centre |
OPD Block, Room No.1 & 2, 175 NSK
Salai, Chennai, TAMILNADU, 600026
Chennai
TAMIL NADU |
044-24814261
doc_suresh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethical Review Board, St. Johns Medical College |
Approved |
| Site 1: IEC - Kokilaben Dhirubhai Ambani Hospital |
Approved |
| Site 2: IEC - Sree Chitra Tirunal Institute for Medical Sciences & Technology |
Not Applicable |
| Site 3: Institutional Ethics Committee, NIMS |
Approved |
| Site 4: Institutional Ethics Committee |
Approved |
| Site 5: National Health & Education Society |
Approved |
| The Ethics Committee,175 NSK Salai, Chennai, Tamil Nadu |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Parkinson Disease, (1) ICD-10 Condition: G20||Parkinsons disease, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preladenant (SCH 420814) |
2, 5, or 10 mg Preladenant tablets, given orally twice daily for 40 weeks |
| Comparator Agent |
Rasagiline |
1 mg Rasagiline tablet given orally once a day for 40 weeks |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
- Participants who have completed the 12-week treatment period of the parent trial, P04938 or P07037.
- Participants must be willing and able to provide written informed consent for P06153.
- Participants must be able to adhere to dose and visit schedules.
- Participants must be taking levo-dopa (L-dopa).
- Participants may be taking additional adjunct PD medications (e.g., dopamine agonists, entacapone).
- Each participant must have results of clinical laboratory tests (hematology, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator as evidenced by the last available test results from the parent study (P04938 or P07037), and no results fall within the parameters for exclusion described below in the exclusion criterion for liver-related findings.
- There has been no change in, or there has been no finding to warrant checking, serology status (for cytomegalovirus [CMV], Epstein-Barr virus [EBV], and Hepatitis B, C, and E).
- Each participant must have results of a physical examination within normal limits, including blood pressure, within normal limits or clinically acceptable limits to the investigator, and not within the parameters for exclusion described below in the exclusion criterion for blood pressure.
- All participants who are sexually active or plan to be sexually active agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must not donate sperm within 2 weeks after the last dose of study drug. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
- Any participant who discontinued from P04938 or P07037 for any reason.
- Any participant with a severe or ongoing unstable medical condition (e.g. any form of clinically significant cardiac disease symptomatic orthostatic hypotension seizures or alcohol/drug dependence).
- Any participant with a history of poorly controlled diabetes (e.g. HbA1c greater than 8.5) or significantly abnormal renal function (e.g. creatinine greater than 2.0 mg/dL) in the opinion of the investigator.
- As a continuation of the liver-related withdrawal criteria from the parent studies (P04938 and P07037) any participant with elevated values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) or total bilirubin (T BIL) as evidenced by the most recent chemistry panel results in the parent study meeting any one of the following criteria:
- ALT or AST greater than 8 x upper limit of normal (ULN).
- ALT or AST greater than 5 x ULN for more than 2 weeks.
- ALT or AST greater than 3 x ULN and (T-BIL greater than 2 x ULN or international normalized ratio [INR] greater than 1.5 that is not due to anti-coagulation) at the same visit.
- ALT or AST greater than 3 x ULN with the appearance of worsening fatigue nausea vomiting right upper quadrant pain or tenderness fever rash and/or eosinophilia (greater than 5%).
- As a continuation of the blood pressure (BP) withdrawal criteria from the parent study (P04938 or P07037) any participant meeting the following criteria for the second of two consecutive visits separated by 7 days (i.e. the participant met one of the BP criteria once already 7 days before the P06153 screening visit):
- Systolic BP greater than or equal to 180 mm Hg or diastolic BP greater than or equal to 105 mm Hg or
- An elevation from baseline BP in the parent study (P04938 or P07037) of systolic BP greater than or equal to 40 mm Hg or diastolic BP greater than or equal to 20 mm Hg.
- A participant must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer in situ cervical cancer or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection.
- Any participant with an average daily consumption of more than three 4-ounce glasses (118 mL) of wine or the equivalent.
- A participant must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (e.g. Stilton) for a prespecified time window before the trial during the trial and for 2 weeks after the trial.
- Any participant with allergy/sensitivity to the investigational products or their excipients.
- Any female participant breast feeding or considering breast feeding.
- Any female participant pregnant or intending to become pregnant.
- Any participant with any clinically significant condition or situation other than the condition being studied that in the opinion of the investigator would interfere with the trial evaluations or optimal participation in the trial.
- Any participant with a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence of systolic blood pressure (SBP) ≥ 180 mm Hg
2. Incidence of diastolic blood pressure (DBP) ≥ 105 mm Hg
3. Incidence of alanine aminotransferase (ALT) ≥ 3 x upper limit of normal and with a ≥10% increase from baseline
4. Incidence of aspartate aminotransferase (AST) ≥ 3 x upper limit of normal and with a ≥10% increase from baseline
5. Columbia Suicide Severity Rating Scale (CSSRS): Suicidality, Suicidal Behavior, Suicidal Ideation
6. Epworth Sleepiness Scale Score |
1.Up to 42 weeks from the beginning of P06153
2.Up to 42 weeks from the beginning of P06153
3.Up to 42 weeks from the beginning of P06153
4.Up to 42 weeks from the beginning of P06153
5.Up to 40 weeks from the beginning of P06153
6.Screening and 40 weeks from the beginning of P06153 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To characterize the long-term efficacy of preladenant in subjects with
moderate to severe PD. |
Up to 42 weeks from the beginning of P06153 |
|
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Target Sample Size
|
Total Sample Size="750"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/07/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/03/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="2"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NA |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
The purpose of this trial is to assess safety data collected for up to 52 weeks (from the beginning of P04938 or P07037 to the end of P06153) and to characterize the efficacy of preladenant over the same time period in participants with moderate to severe Parkinson’s disease (PD).
A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double Dummy Extension Study of
Preladenant in Subjects With Moderate to Severe Parkinson’s Disease
Number of Trial Centers: Approximately 163 sites.
Duration of Participation: Each subject will participate for approximately 42 weeks in P06153 (ie, 40
weeks of active treatment followed by a 2-week Safety Follow-Up Visit).
Duration of Trial: The trial will require approximately 3 years from the beginning to the end of the
overall trial (first subject signing informed consent to last contact with last subject).
Preladenant is a tablet. Rasagiline will be supplied as a capsule. A placebo tablet matching preladen
will be available; and a placebo capsule matching rasagiline also will be available.
During the 40-week Treatment Period, subjects will receive one tablet and one capsule orally each
morning and one tablet orally each evening in a double-blind, double-dummy design
AUSTRIA
BRAZIL
BULGARIA
CANADA
CZECH REPUBLIC
FINLAND
FRANCE
GERMANY
INDIA
ISRAEL
ITALY
NETHERLANDS
PERU
POLAND
RUSSIA
SPAIN
TURKEY
UNITED KINGDOM
USA |