- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537017
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
January 19, 2021 updated by: Merck Sharp & Dohme LLC
A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)
The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist.
All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must have participated in P04501.
- Participants must be >=30 years of age, with a diagnosis of moderate to severe idiopathic Parkinson's disease.
- Participants must have been on a regimen of L-Dopa and/or a dopamine agonist.
Exclusion Criteria:
- Participants who discontinued from Study P04501 because they experienced a serious adverse event (SAE)
- Participants with any form of drug-induced or atypical parkinsonism, cognitive impairment, or psychosis
- Participants taking tolcapone
- Participants who are participating in any other clinical study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Preladenant 5 mg BID
Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
|
5 mg BID capsules
Other Names:
Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease.
L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).
Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experienced at Least One Adverse Event
Time Frame: Up to 42 weeks
|
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.
|
Up to 42 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Spent in "Off" State Per Day
Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Participant diaires recorded time spent in the "off" state at half-hourly intervals for at least 3 full days before scheduled visits.
"Off" time is defined as when the participant's medication is not working as subjectively determined by the participant and his/her physician.
Higher "off" time values relative to Baseline (BL) signify that the Parkinson's disease symptoms are worse (i.e., participant can only move slowly or not at all).
BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501.
Endpoint refers to the last observed result for participants within P05175.
|
Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Awake Time Per Day in the "on" State
Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Participant diaries recorded time spent in the "on" state at half-hourly intervals for at least 3 full days before scheduled visits.
"On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician.
Higher "on" time values relative to BL mean that the Parkinson's disease symptoms are better or absent (i.e., participant can move well).
BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501.
Endpoint refers to the last observed result for participants within P05175.
|
Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Time Spent in the "on" State With no Dyskinesias
Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Participant diaries recorded time spent in the "on" state with no dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits.
"On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician.
Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time.
Higher values relative to BL signify an improvement in the Parkinson's disease symptoms (i.e., participant can move well) concomitant with no dyskinesias.
BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501.
Endpoint refers to the last observed result for participants within P05175.
|
Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Time Spent in the "on" State With Troublesome Dyskinesias
Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Participant diaries recorded time spent in the "on" state with troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits.
"On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician.
Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time; troublesome dyskinesias interfere with function or cause discomfort.
Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with troublesome dyskinesias.
BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501.
Endpoint refers to the last observed result for participants within P05175.
|
Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Time Spent in the "on" State Without Troublesome Dyskinesia
Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Participant diaries recorded time spent in the "on" state without troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits.
"On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician.
Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time; troublesome dyskinesias interfere with function or cause discomfort.
Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with absence of troublesome dyskinesias.
BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501.
Endpoint refers to the last observed result for participants within P05175.
|
Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Absolute Duration of Dyskinesias
Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Participant diaries recorded time spent in the "on" state with dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits.
"On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician.
Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time.
Higher values relative to BL signify worsening of dyskinesia (i.e., more time spent with dyskinesia).
BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501.
Endpoint refers to the last observed result for participants within P05175.
|
Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Total Sleep Time
Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Participant diaries recorded time spent in the sleep state at half-hourly intervals for at least 3 full days before scheduled visits.
BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501.
Endpoint refers to the last observed result for participants within P05175.
|
Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2007
Primary Completion (Actual)
November 19, 2009
Study Completion (Actual)
November 19, 2009
Study Registration Dates
First Submitted
September 27, 2007
First Submitted That Met QC Criteria
September 27, 2007
First Posted (Estimate)
September 28, 2007
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 19, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Synucleinopathies
- Parkinson Disease
- Nervous System Diseases
- Brain Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Central Nervous System Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Levodopa
Other Study ID Numbers
- P05175
- MK-3814-021 (Other Identifier: Merck)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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