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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00537017

Enrollment

140

Registered

2007-09-28

Start date

2007-11-23

Completion date

2009-11-19

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DRUGPreladenant

5 mg BID capsules

DRUGL-dopa

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).

DRUGOther Parkinson's Disease treatments

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Experienced at Least One Adverse Event	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.

Secondary

Measure	Time frame	Description
Awake Time Per Day in the on State	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.
Time Spent in the on State With no Dyskinesias	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.
Time Spent in the on State With Troublesome Dyskinesias	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.
Time Spent in Off State Per Day	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.
Absolute Duration of Dyskinesias	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.
Total Sleep Time	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.
Time Spent in the on State Without Troublesome Dyskinesia	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.

Participant flow

Recruitment details

Participants from Study P04501 (NCT00406029) were enrolled into this study (Treatment Phase \[TP\] and Follow-up Phase \[FUP\]).

Pre-assignment details

Screening for entry into the TP was performed over an 8 day period.

Participants by arm

Arm	Count
Preladenant 5 mg BID Preladenant 5 mg 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.	140
Total	140

Withdrawals & dropouts

Period	Reason	FG000
Follow-up Phase	Withdrawal by Subject	9
Treatment Phase	Adverse Event	19
Treatment Phase	Protocol Violation	2
Treatment Phase	Withdrawal by Subject	13

Baseline characteristics

Characteristic	Preladenant 5 mg BID
Age, Continuous	62.9 Years STANDARD_DEVIATION 9.8
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	95 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	96 / 140
serious Total, serious adverse events	22 / 140

Outcome results

Primary

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.

Time frame: Up to 42 weeks

Population: All participants who received treatment with study drug were included in the analysis.

Arm	Measure	Value (NUMBER)
Preladenant 5 mg BID	Number of Participants Who Experienced at Least One Adverse Event	123 Participants

Secondary

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.

Time frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36