Parkinson DiseasePhase 3NCT01155466
A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)
A Phase 3 study testing Preladenant 2 mg tablet, Preladenant 5 mg tablet and Preladenant 10 mg tablet in people with Parkinson Disease, run by Merck Sharp & Dohme LLC.
Trial summary
When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or dopamine agonists, patients notice that their PD medications wear off sooner than when they first started taking them. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Preladenant 2 mg tablet, Preladenant 5 mg tablet and Preladenant 10 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 778 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2010to 20 Dec 2012
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a diagnosis of moderate to severe idiopathic Parkinson's disease.
- Must have received prior therapy with L dopa for approximately 1 or more years immediately before Screening and must continue to have a beneficial clinical response to L dopa
- Must have been on a stable dopaminergic treatment regimen for at least the 5 weeks immediately before Randomization. Participants receiving other adjunctive treatments (eg, dopamine agonists, anticholinergics, entacapone) or taking only L dopa are permitted, provided the treatment regimen has been taken for at least 5 weeks prior to randomization
- Must be experiencing motor fluctuations with or without dyskinesias within the 4 weeks immediately before Screening, must be experiencing a minimum of 2 hours/day of "off" time, and have a Hoehn \& Yahr stage between 2.5 and 4 when in the "on" state
- Must be capable of maintaining an accurate and complete symptom diary and to adhere to dose and visit schedules with or without the help of a caregiver
- Must have results of a physical examination and screening clinical laboratory tests clinically acceptable to the investigator
- If sexually active or plan to be sexually active agree to use a highly effective method of birth control while in the study and for 2 weeks after the last dose of study drug. Males must also not donate sperm during the trial within 2 weeks after the last dose of study drug
Who cannot join
- Must not have a form of drug induced or atypical parkinsonism, a cognitive impairment, bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history of exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator
- Must not have a history of repeated strokes or head injuries, or a stroke within 6 months of Screening
- Must not have poorly-controlled diabetes or abnormal renal function
- Must not have had surgery for their PD
- Must not be at imminent risk of self-harm or harm to others
- Must not have sleep attacks or compulsive behavior that would interfere with the integrity of the trial or would pose a risk to the subject in participating in the trial
Show all 17Show fewer
- Must not have a systolic blood pressure (BP) ≥150 mm Hg OR diastolic BP ≥95 mm Hg at Screening
- Must not have had any clinically significant cardiovascular event or procedure for 6 months prior to study start, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and must not have heart failure staged New York Heart Association Class III or IV
- Must not have an alanine aminotransferase (ALT) or aspartate amino transferase (AST) ≥3 x the upper limit of normal (ULN) or total bilirubin (T-BIL) ≥1.5 x ULN
- Must not have a history of serologically confirmed hepatic dysfunction (defined as viral infection [Hepatitis B or C; Epstein Barr virus (EBV); cytomegalovirus (CMV)]) or a history of diagnosis of drug or alcohol induced hepatic toxicity or frank hepatitis
- Must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection
- Must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (eg, Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial
- Must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent
- Must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence)
- Must not have allergy/sensitivity to investigational product(s) or its/their excipients
- A female subject must not be breast-feeding, considering breast-feeding, pregnant, or intending to become pregnant
- Must not have used preladenant ever, or any investigational drugs within 90 days immediately before Screening
About this study
Official title: A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938)
When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or dopamine agonists, patients notice that their PD medications wear off sooner than when they first started taking them. This "wearing off" is characterized by the return of symptoms (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an hour. When a patient's PD symptoms have returned, the patient is said to be in the "off" state. When the patient takes another dose of medication, and his/her PD symptoms improve or resolve, the patient is said to be in the "on" state. Antagonism of adenosine Type 2a receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD participants taking a stable dose of L-dopa, as measured by a reduction in "off" time.
- Conditions
- Parkinson Disease
- Being tested
- Preladenant 2 mg tablet, Preladenant 5 mg tablet, Preladenant 10 mg tablet, Placebo to Preladenant Tablet, Rasagiline 1 mg capsule
- Keywords
- Idiopathic Parkinson Disease, Idiopathic Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preladenant 2 mg tabletDrug
Also called SCH 420814
one 2 mg tablet orally twice daily
Preladenant 5 mg tabletDrug
Also called SCH 420814
one 5 mg tablet orally twice daily
Preladenant 10 mg tabletDrug
Also called SCH 420814
one 10 mg tablet orally twice daily
Placebo to Preladenant TabletDrug
one tablet orally twice daily
Rasagiline 1 mg capsuleDrug
Also called Azilect
one 1 mg capsule orally in AM
Placebo to Rasagiline capsuleDrug
one capsule orally in AM
| Study group | Role | What they receive |
|---|---|---|
| Preladenant 2 mg | Experimental | Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks Receives: Drug: Preladenant 2 mg tablet; Drug: Placebo to Rasagiline capsule |
| Preladenant 5 mg | Experimental | Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks Receives: Drug: Preladenant 5 mg tablet; Drug: Placebo to Rasagiline capsule |
| Preladenant 10 mg | Experimental | Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks Receives: Drug: Preladenant 10 mg tablet; Drug: Placebo to Rasagiline capsule |
| Placebo | Placebo comparator | Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks Receives: Drug: Placebo to Preladenant Tablet; Drug: Placebo to Rasagiline capsule |
| Rasagiline 1 mg | Active comparator | Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks Receives: Drug: Placebo to Preladenant Tablet; Drug: Rasagiline 1 mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean "Off" Time
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Measured: Baseline and Week 12
Numberof Participants With Systolic Blood Pressure >=180 mm Hg
The number of participants with Systolic Blood Pressure >=180 mm Hg was reported.
Measured: Up to Week 14
Number of Participants With Diastolic Blood Pressure >=105 mm Hg
The number of participants with Diastolic Blood Pressure >=105 mm Hg was reported.
Measured: Up to Week 14
Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal
The number of participants with alanine aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.
Measured: Up to Week 14
Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal
The number of participants with aspartate aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.
Measured: Up to Week 14
Percentage of Participants With Suicidality
The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.
Measured: Up to Week 12
Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)
The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24.
Measured: Baseline and Week 12
Secondary outcomes (2)
Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean "Off" Time
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit.
Measured: Baseline and Week 12
Change From Baseline at Week 12 in Mean "On" Time Without Troublesome Dyskinesia
When a participant is "on" without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as "off", "on without dyskinesia", "on with non-troublesome dyskinesia", "on with troublesome dyskinesia", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "on without troublesome dyskinesia" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study start14 Jul 2010
- Primary completion20 Dec 2012
- Study completion20 Dec 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 778 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
- NCT01155466
- Sponsor's protocol ID
- P04938
- Other IDs
- 2009-015161-31, CTRI/2011/07/001896, MK-3814-015, 2009
- Status last verified
- Oct 2018
- First submitted
- 30 Jun 2010
- Last updated
- 6 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Hauser RA, Stocchi F, Rascol O, Huyck SB, Capece R, Ho TW, Sklar P, Lines C, Michelson D, Hewitt D. Preladenant as an Adjunctive Therapy With Levodopa in Parkinson Disease: Two Randomized Clinical Trials and Lessons Learned. JAMA Neurol. 2015 Dec;72(12):1491-500. doi: 10.1001/jamaneurol.2015.2268.
PubMed 26523919
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938)
- ClinicalTrials.gov ID
- NCT01155466
- Acronym / sponsor ID
- P04938
- Conditions
- Parkinson Disease
- Keywords
- Idiopathic Parkinson Disease, Idiopathic Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2010 (actual)
- Primary completion
- 20 Dec 2012 (actual)
- Study completion
- 20 Dec 2012 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 11 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or dopamine agonists, patients notice that their PD medications wear off sooner than when they first started taking them. This "wearing off" is characterized by the return of symptoms (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an hour. When a patient's PD symptoms have returned, the patient is said to be in the "off" state. When the patient takes another dose of medication, and his/her PD symptoms improve or resolve, the patient is said to be in the "on" state. Antagonism of adenosine Type 2a receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD participants taking a stable dose of L-dopa, as measured by a reduction in "off" time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Preladenant 2 mg | Experimental | Drug: Preladenant 2 mg tablet, Drug: Placebo to Rasagiline capsulePreladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks |
| Preladenant 5 mg | Experimental | Drug: Preladenant 5 mg tablet, Drug: Placebo to Rasagiline capsulePreladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks |
| Preladenant 10 mg | Experimental | Drug: Preladenant 10 mg tablet, Drug: Placebo to Rasagiline capsulePreladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo to Preladenant Tablet, Drug: Placebo to Rasagiline capsulePlacebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks |
| Rasagiline 1 mg | Active comparator | Drug: Placebo to Preladenant Tablet, Drug: Rasagiline 1 mg capsuleRasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have a diagnosis of moderate to severe idiopathic Parkinson's disease.
- Must have received prior therapy with L dopa for approximately 1 or more years immediately before Screening and must continue to have a beneficial clinical response to L dopa
- Must have been on a stable dopaminergic treatment regimen for at least the 5 weeks immediately before Randomization. Participants receiving other adjunctive treatments (eg, dopamine agonists, anticholinergics, entacapone) or taking only L dopa are permitted, provided the treatment regimen has been taken for at least 5 weeks prior to randomization
- Must be experiencing motor fluctuations with or without dyskinesias within the 4 weeks immediately before Screening, must be experiencing a minimum of 2 hours/day of "off" time, and have a Hoehn \& Yahr stage between 2.5 and 4 when in the "on" state
- Must be capable of maintaining an accurate and complete symptom diary and to adhere to dose and visit schedules with or without the help of a caregiver
Key exclusion criteria (17 listed)
- Must not have a form of drug induced or atypical parkinsonism, a cognitive impairment, bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history of exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator
- Must not have a history of repeated strokes or head injuries, or a stroke within 6 months of Screening
- Must not have poorly-controlled diabetes or abnormal renal function
- Must not have had surgery for their PD
- Must not be at imminent risk of self-harm or harm to others
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 |
|---|---|---|
| Preladenant 2 mg tabletAlso: SCH 420814one 2 mg tablet orally twice daily | Drug | Preladenant 2 mg |
| Preladenant 5 mg tabletAlso: SCH 420814one 5 mg tablet orally twice daily | Drug | Preladenant 5 mg |
| Preladenant 10 mg tabletAlso: SCH 420814one 10 mg tablet orally twice daily | Drug | Preladenant 10 mg |
| Placebo to Preladenant Tabletone tablet orally twice daily | Drug | Placebo, Rasagiline 1 mg |
| Rasagiline 1 mg capsuleAlso: Azilectone 1 mg capsule orally in AM | Drug | Rasagiline 1 mg |
| Placebo to Rasagiline capsuleone capsule orally in AM | Drug | Placebo, Preladenant 10 mg, Preladenant 2 mg, Preladenant 5 mg |
Primary outcome
Change From Baseline in Mean "Off" Time
Time frame: Baseline and Week 12
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Numberof Participants With Systolic Blood Pressure >=180 mm Hg
Time frame: Up to Week 14
The number of participants with Systolic Blood Pressure >=180 mm Hg was reported.
Number of Participants With Diastolic Blood Pressure >=105 mm Hg
Time frame: Up to Week 14
The number of participants with Diastolic Blood Pressure >=105 mm Hg was reported.
Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal
Time frame: Up to Week 14
The number of participants with alanine aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.
Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal
Time frame: Up to Week 14
The number of participants with aspartate aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.
Percentage of Participants With Suicidality
Time frame: Up to Week 12
The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.
Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)
Time frame: Baseline and Week 12
The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24.
2 secondary outcomes
Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean "Off" Time
Time frame: Baseline and Week 12
Change From Baseline at Week 12 in Mean "On" Time Without Troublesome Dyskinesia
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26523919Hauser RA, Stocchi F, Rascol O, Huyck SB, Capece R, Ho TW, Sklar P, Lines C, Michelson D, Hewitt D. Preladenant as an Adjunctive Therapy With Levodopa in Parkinson Disease: Two Randomized Clinical Trials and Lessons Learned. JAMA Neurol. 2015 Dec;72(12):1491-500. doi: 10.1001/jamaneurol.2015.2268.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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 3 study testing Preladenant 2 mg tablet, Preladenant 5 mg tablet and Preladenant 10 mg tablet in people with Parkinson Disease, 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 7 inclusion and 17 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 6 Nov 2018. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Feb 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?
Change From Baseline in Mean "Off" Time (time frame: Baseline and Week 12). The study lists 7 primary outcomes in all. 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 NCT01155466, 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 6 Nov 2018.