Parkinson DiseasePhase 2NCT00537017
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
A Phase 2 study testing Preladenant, L-dopa and Other Parkinson's Disease treatments in people with Parkinson Disease and Neurodegenerative Diseases, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases
- What is being tested?
- Preladenant, L-dopa and Other Parkinson's Disease treatments
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2007to 19 Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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."
- Conditions
- Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Movement Disorders, Brain Diseases
- Being tested
- Preladenant, L-dopa, Other Parkinson's Disease treatments
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Movement Disorders, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreladenantDrug
Also called SCH 420814; Privadenant
5 mg BID capsules
L-dopaDrug
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).
Other Parkinson's Disease treatmentsDrug
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 group | Role | What they receive |
|---|---|---|
| Preladenant 5 mg BID | Experimental | 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. Receives: Drug: Preladenant; Drug: L-dopa; Drug: Other Parkinson's Disease treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 42 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study start23 Nov 2007
- Primary completion19 Nov 2009
- Study completion19 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537017
- Sponsor's protocol ID
- P05175
- Other IDs
- MK-3814-021
- Status last verified
- Jan 2021
- First submitted
- 27 Sep 2007
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Factor SA, Wolski K, Togasaki DM, Huyck S, Cantillon M, Ho TW, Hauser RA, Pourcher E. Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov Disord. 2013 Jun;28(6):817-20. doi: 10.1002/mds.25395. Epub 2013 Apr 15.
PubMed 23589371
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)
- ClinicalTrials.gov ID
- NCT00537017
- Acronym / sponsor ID
- P05175
- Conditions
- Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Movement Disorders, Brain Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2007 (actual)
- Primary completion
- 19 Nov 2009 (actual)
- Study completion
- 19 Nov 2009 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Posted 6 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preladenant 5 mg BID | Experimental | Drug: Preladenant, Drug: L-dopa, Drug: Other Parkinson's Disease treatmentsPreladenant 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreladenantAlso: SCH 420814; Privadenant5 mg BID capsules | Drug | Preladenant 5 mg BID |
| L-dopaParticipants 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). | Drug | Preladenant 5 mg BID |
| Other Parkinson's Disease treatmentsParticipants 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. | Drug | Preladenant 5 mg BID |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
Absolute Duration of Dyskinesias
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23589371Factor SA, Wolski K, Togasaki DM, Huyck S, Cantillon M, Ho TW, Hauser RA, Pourcher E. Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov Disord. 2013 Jun;28(6):817-20. doi: 10.1002/mds.25395. Epub 2013 Apr 15.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preladenant, L-dopa and Other Parkinson's Disease treatments in people with Parkinson Disease and Neurodegenerative Diseases, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced at Least One Adverse Event (time frame: Up to 42 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.