Trial Outcomes & Findings for Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175) (NCT NCT00537017)

NCT ID: NCT00537017

Last Updated: 2021-02-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 140 participants
• Primary outcome timeframe: Up to 42 weeks
• Results posted on: 2021-02-02

Participant Flow

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

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

Participant milestones

Measure	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.
Treatment Phase STARTED	140
Treatment Phase COMPLETED	106
Treatment Phase NOT COMPLETED	34
Follow-up Phase STARTED	135
Follow-up Phase COMPLETED	126
Follow-up Phase NOT COMPLETED	9

Reasons for withdrawal

Measure	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.
Treatment Phase Adverse Event	19
Treatment Phase Withdrawal by Subject	13
Treatment Phase Protocol Violation	2
Follow-up Phase Withdrawal by Subject	9

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Preladenant 5 mg BID n=140 Participants 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.
Age, Continuous	62.9 Years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 42 weeks

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

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Number of Participants Who Experienced at Least One Adverse Event	123 Participants

SECONDARY outcome

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

Population: All participants with a baseline value and at least one post-baseline value were included in the analysis.

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Time Spent in "Off" State Per Day P04501 BL (n=133)	5.6 Hours/day Standard Deviation 2.1
Time Spent in "Off" State Per Day P04501 BL_LA (n=133)	4.3 Hours/day Standard Deviation 3.0
Time Spent in "Off" State Per Day Week 4 (n=132)	4.2 Hours/day Standard Deviation 2.8
Time Spent in "Off" State Per Day Week 8 (n=119)	4.0 Hours/day Standard Deviation 3.0
Time Spent in "Off" State Per Day Week 12 (n=119)	3.7 Hours/day Standard Deviation 2.8
Time Spent in "Off" State Per Day Week 24 (n=110)	3.7 Hours/day Standard Deviation 3.0
Time Spent in "Off" State Per Day Week 36 (n=99)	4.1 Hours/day Standard Deviation 3.3
Time Spent in "Off" State Per Day Endpoint (n=133)	4.2 Hours/day Standard Deviation 3.3

SECONDARY outcome

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

Population: All participants with a baseline value and at least one post-baseline value were included in the analysis.

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Awake Time Per Day in the "on" State P04501 BL (n=133)	10.6 hours/day Standard Deviation 2.1
Awake Time Per Day in the "on" State P04501 BL (Last Assessment) (n=133)	11.7 hours/day Standard Deviation 3.2
Awake Time Per Day in the "on" State Week 4 (n=132)	11.9 hours/day Standard Deviation 2.9
Awake Time Per Day in the "on" State Week 8 (n=119)	12.0 hours/day Standard Deviation 3.0
Awake Time Per Day in the "on" State Week 12 (n=119)	12.1 hours/day Standard Deviation 3.2
Awake Time Per Day in the "on" State Week 24 (n=110)	12.2 hours/day Standard Deviation 3.4
Awake Time Per Day in the "on" State Week 36 (n=99)	11.9 hours/day Standard Deviation 3.5
Awake Time Per Day in the "on" State Endpoint (n=133)	11.8 hours/day Standard Deviation 3.4

SECONDARY outcome

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

Population: All participants with a baseline value and at least one post-baseline value were included in the analysis.

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Time Spent in the "on" State With no Dyskinesias P04501 BL (n=133)	6.3 hours/day Standard Deviation 3.2
Time Spent in the "on" State With no Dyskinesias P04501 BL_LA (n=133)	7.1 hours/day Standard Deviation 4.4
Time Spent in the "on" State With no Dyskinesias Week 4 (n=132)	6.8 hours/day Standard Deviation 4.1
Time Spent in the "on" State With no Dyskinesias Week 8 (n=119)	6.9 hours/day Standard Deviation 3.9
Time Spent in the "on" State With no Dyskinesias Week 12 (n=119)	7.0 hours/day Standard Deviation 4.3
Time Spent in the "on" State With no Dyskinesias Week 24 (n=110)	6.9 hours/day Standard Deviation 4.4
Time Spent in the "on" State With no Dyskinesias Week 36 (n=99)	6.9 hours/day Standard Deviation 4.4
Time Spent in the "on" State With no Dyskinesias Endpoint (n=133)	6.6 hours/day Standard Deviation 4.3

SECONDARY outcome

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

Population: All participants with a baseline value and at least one post-baseline value were included in the analysis.

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Time Spent in the "on" State With Troublesome Dyskinesias Week 36 (n=99)	1.4 hours/day Standard Deviation 2.4
Time Spent in the "on" State With Troublesome Dyskinesias P04501 BL (n=133)	1.0 hours/day Standard Deviation 1.6
Time Spent in the "on" State With Troublesome Dyskinesias P04501 BL_LA (n=133)	1.2 hours/day Standard Deviation 2.1
Time Spent in the "on" State With Troublesome Dyskinesias Week 4 (n=132)	1.4 hours/day Standard Deviation 2.4
Time Spent in the "on" State With Troublesome Dyskinesias Week 8 (n=119)	1.3 hours/day Standard Deviation 1.9
Time Spent in the "on" State With Troublesome Dyskinesias Week 12 (n=119)	1.3 hours/day Standard Deviation 2.1
Time Spent in the "on" State With Troublesome Dyskinesias Week 24 (n=110)	1.4 hours/day Standard Deviation 2.4
Time Spent in the "on" State With Troublesome Dyskinesias Endpoint (n=133)	1.5 hours/day Standard Deviation 2.4

SECONDARY outcome

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

Population: All participants with a baseline value and at least one post-baseline value were included in the analysis.

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Time Spent in the "on" State Without Troublesome Dyskinesia P04501 BL (n=133)	3.3 hours/day Standard Deviation 2.8
Time Spent in the "on" State Without Troublesome Dyskinesia P04501 BL_LA (n=133)	3.4 hours/day Standard Deviation 3.4
Time Spent in the "on" State Without Troublesome Dyskinesia Week 4 (n=132)	3.7 hours/day Standard Deviation 3.5
Time Spent in the "on" State Without Troublesome Dyskinesia Week 8 (n=119)	3.8 hours/day Standard Deviation 3.7
Time Spent in the "on" State Without Troublesome Dyskinesia Week 12 (n=119)	3.8 hours/day Standard Deviation 3.9
Time Spent in the "on" State Without Troublesome Dyskinesia Week 24 (n=110)	3.8 hours/day Standard Deviation 3.7
Time Spent in the "on" State Without Troublesome Dyskinesia Week 36 (n=99)	3.6 hours/day Standard Deviation 3.7
Time Spent in the "on" State Without Troublesome Dyskinesia Endpoint (n=133)	3.8 hours/day Standard Deviation 3.6

SECONDARY outcome

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

Population: All participants with a baseline value and at least one post-baseline value were included in the analysis.

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Absolute Duration of Dyskinesias Week 36 (n=99)	5.0 hours/day Standard Deviation 4.5
Absolute Duration of Dyskinesias P04501 BL (n=133)	4.3 hours/day Standard Deviation 3.5
Absolute Duration of Dyskinesias P04501 BL_LA (n=133)	4.6 hours/day Standard Deviation 4.3
Absolute Duration of Dyskinesias Week 4 (n=132)	5.1 hours/day Standard Deviation 4.5
Absolute Duration of Dyskinesias Week 8 (n=119)	5.1 hours/day Standard Deviation 4.5
Absolute Duration of Dyskinesias Week 12 (n=119)	5.2 hours/day Standard Deviation 4.6
Absolute Duration of Dyskinesias Week 24 (n=110)	5.2 hours/day Standard Deviation 4.6
Absolute Duration of Dyskinesias Endpoint (n=133)	5.3 hours/day Standard Deviation 4.5

SECONDARY outcome

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

Population: All participants with a baseline value and at least one post-baseline value were included in the analysis.

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.

Outcome measures

Measure	Preladenant 5 mg BID n=140 Participants 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.
Total Sleep Time P04501 BL (n=133)	7.6 hours/day Standard Deviation 1.6
Total Sleep Time P04501 BL_LA (n=133)	7.8 hours/day Standard Deviation 1.7
Total Sleep Time Week 4 (n=132)	7.7 hours/day Standard Deviation 1.6
Total Sleep Time Week 8 (n=119)	7.8 hours/day Standard Deviation 1.7
Total Sleep Time Week 12 (n=119)	7.8 hours/day Standard Deviation 1.7
Total Sleep Time Week 24 (n=110)	7.7 hours/day Standard Deviation 1.9
Total Sleep Time Week 36 (n=99)	7.9 hours/day Standard Deviation 1.7
Total Sleep Time Endpoint (n=133)	7.8 hours/day Standard Deviation 1.6

Adverse Events

Preladenant 5 mg BID

Serious events: 22 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Measure	Preladenant 5 mg BID n=140 participants at risk 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.
Cardiac disorders Myocardial Infarction	1.4% 2/140 • Number of events 2 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Eye disorders Amaurosis Fugax	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Gastrointestinal disorders Constipation	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Gastrointestinal disorders Diarrhoea	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
General disorders Abasia	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
General disorders Chest Pain	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Infections and infestations Pneumonia	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Injury, poisoning and procedural complications Concussion	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Injury, poisoning and procedural complications Fall	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Injury, poisoning and procedural complications Road Traffic Accident	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Investigations Alanine Aminotransferase Increased	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Investigations Aspartate Aminotransferase Increased	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Investigations Blood Alkaline Phosphatase Increased	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Investigations Gamma-Glutamyltransferase Increased	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Musculoskeletal and connective tissue disorders Back Pain	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Akinesia	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Dyskinesia	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Parkinson's Disease	1.4% 2/140 • Number of events 2 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Transient Ischaemic Attack	1.4% 2/140 • Number of events 2 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Psychiatric disorders Completed Suicide	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Psychiatric disorders Delirium	0.71% 1/140 • Number of events 2 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Psychiatric disorders Hallucination, Visual	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Psychiatric disorders Hallucinations, Mixed	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Reproductive system and breast disorders Cystocele	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Surgical and medical procedures Benign Tumour Excision	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Surgical and medical procedures Inguinal Hernia Repair	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Surgical and medical procedures Shoulder Arthroplasty	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Vascular disorders Deep Vein Thrombosis	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Vascular disorders Orthostatic Hypotension	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Vascular disorders Thrombosis	0.71% 1/140 • Number of events 1 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.

Other adverse events

Measure	Preladenant 5 mg BID n=140 participants at risk 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.
Gastrointestinal disorders Constipation	17.9% 25/140 • Number of events 26 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Gastrointestinal disorders Diarrhoea	7.9% 11/140 • Number of events 14 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Gastrointestinal disorders Nausea	6.4% 9/140 • Number of events 10 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Infections and infestations Influenza	6.4% 9/140 • Number of events 11 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Infections and infestations Nasopharyngitis	6.4% 9/140 • Number of events 9 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Injury, poisoning and procedural complications Fall	12.1% 17/140 • Number of events 28 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Investigations Blood Creatine Phosphokinase Increased	6.4% 9/140 • Number of events 10 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Musculoskeletal and connective tissue disorders Arthralgia	9.3% 13/140 • Number of events 15 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Musculoskeletal and connective tissue disorders Back Pain	9.3% 13/140 • Number of events 13 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Musculoskeletal and connective tissue disorders Pain In Extremity	5.7% 8/140 • Number of events 10 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Dyskinesia	32.9% 46/140 • Number of events 63 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Headache	9.3% 13/140 • Number of events 17 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Parkinson's Disease	12.9% 18/140 • Number of events 23 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Nervous system disorders Somnolence	10.7% 15/140 • Number of events 16 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.
Psychiatric disorders Insomnia	7.9% 11/140 • Number of events 12 • Up to 42 weeks All participants who received treatment with study drug were included in the analysis.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
• Publication restrictions are in place

Restriction type: OTHER