Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)

Conditions
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Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Movement Disorders, Brain Diseases

Intervention / Treatment
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* Drug: Preladenant
* Drug: L-dopa
* Drug: Other Parkinson's Disease treatments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preladenant 5 mg BID<br>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. | Drug: Preladenant<br>* 5 mg BID capsules<br>* Other names: SCH 420814; Privadenant;Drug: L-dopa<br>* 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).<br>Drug: Other Parkinson's Disease treatments<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced at Least One Adverse Event | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |