Parkinson DiseasePhase 1NCT00845000
Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)
A Phase 1 study testing SCH 420814 10 mg, SCH 420814 100 mg and Levodopa in people with Parkinson Disease, run by Merck Sharp & Dohme LLC.
Trial summary
This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- SCH 420814 10 mg, SCH 420814 100 mg and Levodopa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2009to 14 May 2010
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have a diagnosis of idiopathic PD based on history, exam and any relevant laboratory tests
- Participants must have been treated with levodopa for one or more years
- Participants must have motor fluctuations that can be measured as a 10% change in tapping speed between "on" and "off" and concurrent motor Unified PD Rating Scale (UPDRS) must also show a 20% improvement when "on"
- Participants must have dyskinesia when "on" measured as at least 2 in one or more body parts on scale using 0 (absent) to 4 (severe) for four limbs, trunk, neck and face (total 7 body parts and 28 points)
- Participant must be free of any clinically significant disease that would interfere with the study evaluations
- Female participants must be postmenopausal and/or surgically sterilized and have a negative serum pregnancy test at the screening visit and a negative urine or serum pregnancy test upon each admission to the study center
- Premenopausal, unsterilized female participants have to agree to use a medically accepted method of contraception
- Male participants must agree to use a medically accepted method of contraception as or abstain from sexual intercourse during the trial and for 2 months after stopping the medication.
Who cannot join
- Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating
- Participants with dementia (mini-mental state examination [MMSE] <23), hallucinations, confusion, major psychiatric disorders, and unstable medical conditions
- Participants with any stable surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- Participants with a positive screen for drugs of abuse
- Participants who are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Participants who are currently participating in another medical interventional clinical study or have participated in a medical interventional clinical study within 30 days and who have previously received this compound.
About this study
Official title: Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients
This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices. This trial will investigate the effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian actions of a levodopa infusion. The study will examine 10 mg ("low dose") or 100 mg ("high dose") study drug, given as single, oral administrations in conjunction with intravenous (IV) levodopa infusion and oral carbidopa.
- Conditions
- Parkinson Disease
- Being tested
- SCH 420814 10 mg, SCH 420814 100 mg, Placebo, Levodopa, Carbidopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 420814 10 mgDrug
one 10-mg capsule, orally, at hour 0 of treatment period
SCH 420814 100 mgDrug
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
PlaceboDrug
Placebo capsule, oral, at hour 0 of treatment period
LevodopaDrug
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
CarbidopaDrug
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
| Study group | Role | What they receive |
|---|---|---|
| SCH 420814 10 mg→SCH 420814 100 mg→Placebo | Experimental | Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. Receives: Drug: SCH 420814 10 mg; Drug: SCH 420814 100 mg; Drug: Placebo; Drug: Levodopa; Drug: Carbidopa |
| SCH 420814 100 mg→Placebo→ SCH 420814 10 mg | Experimental | Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. Receives: Drug: SCH 420814 10 mg; Drug: SCH 420814 100 mg; Drug: Placebo; Drug: Levodopa; Drug: Carbidopa |
| Placebo→SCH 420814 10 mg→SCH 420814 100 mg | Experimental | Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. Receives: Drug: SCH 420814 10 mg; Drug: SCH 420814 100 mg; Drug: Placebo; Drug: Levodopa; Drug: Carbidopa |
| SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg | Experimental | Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. Receives: Drug: SCH 420814 10 mg; Drug: SCH 420814 100 mg; Drug: Placebo; Drug: Levodopa; Drug: Carbidopa |
| SCH 420814 100 mg→ SCH 420814 10 mg→Placebo | Experimental | Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. Receives: Drug: SCH 420814 10 mg; Drug: SCH 420814 100 mg; Drug: Placebo; Drug: Levodopa; Drug: Carbidopa |
| Placebo→ SCH 420814 100 mg→SCH 420814 10 mg | Experimental | Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. Receives: Drug: SCH 420814 10 mg; Drug: SCH 420814 100 mg; Drug: Placebo; Drug: Levodopa; Drug: Carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak Dyskinesia Score
Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.
Measured: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Secondary outcomes (3)
Mean Peak Finger Tapping Score
Tapping was measured with two manual counters with keys that were depressed to register a count. The participant alternately tapped each counter using the index finger of the more affected hand for 60 seconds and was not allowed to use more than one finger to tap. The participant was instructed to tap as rapidly as possible while being timed for 60 seconds. The counts were recorded for the two counters at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The peak tapping score was recorded for each participant regardless of what timepoint the score was achieved. The mean peak finger tapping score was calculated using the individual peak values.
Measured: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Mean Peak Tremor Score
Tremor was scored on a scale of 0 (absent), 1 (mild, 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse tremor observed during the time spent with participant while taking other study measurements(vital signs, drawing samples, performing the tapping and walking tasks). Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The tremor score was the sum of scores for seven body parts. The peak tremor score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating more effects of the tremors. The mean peak tremor score was calculated using the individual peak values.
Measured: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Mean Peak Walking Speed
Walking speed assessment began with the participant being seated in an armless chair. Then while being timed, the participant stood up with their arms crossed on their chest and walked 6 meters, turned around, returned to the chair and sat. Timing was stopped when the participant's buttocks hit the chair and the total time was recorded. If the participant could not arise in 60 seconds, 60 seconds was entered in this line of the report form and the participant was tested again but allowed to push off to get out of the chair. Sixty seconds was the maximum time allowed to complete the walking assessment, thus 60 seconds was recorded as the time if they could not complete the task within this time limit. Walking speed was assessed at Hours 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7.0 and 8. The peak walking speed was recorded for each participant regardless of what timepoint the score was achieved. The mean peak walking speed was calculated using the individual peak values.
Measured: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study start21 Apr 2009
- Primary completion30 Apr 2010
- Study completion14 May 2010
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845000
- Sponsor's protocol ID
- P05550
- Other IDs
- MK-3814-023
- Status last verified
- Oct 2018
- First submitted
- 13 Feb 2009
- Last updated
- 7 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients
- ClinicalTrials.gov ID
- NCT00845000
- Acronym / sponsor ID
- P05550
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Study start
- 21 Apr 2009 (actual)
- Primary completion
- 30 Apr 2010 (actual)
- Study completion
- 14 May 2010 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Posted 21 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices. This trial will investigate the effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian actions of a levodopa infusion. The study will examine 10 mg ("low dose") or 100 mg ("high dose") study drug, given as single, oral administrations in conjunction with intravenous (IV) levodopa infusion and oral carbidopa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SCH 420814 10 mg→SCH 420814 100 mg→Placebo | Experimental | Drug: SCH 420814 10 mg, Drug: SCH 420814 100 mg, Drug: Placebo, Drug: Levodopa, Drug: CarbidopaParticipants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. |
| SCH 420814 100 mg→Placebo→ SCH 420814 10 mg | Experimental | Drug: SCH 420814 10 mg, Drug: SCH 420814 100 mg, Drug: Placebo, Drug: Levodopa, Drug: CarbidopaParticipants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. |
| Placebo→SCH 420814 10 mg→SCH 420814 100 mg | Experimental | Drug: SCH 420814 10 mg, Drug: SCH 420814 100 mg, Drug: Placebo, Drug: Levodopa, Drug: CarbidopaParticipants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. |
| SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg | Experimental | Drug: SCH 420814 10 mg, Drug: SCH 420814 100 mg, Drug: Placebo, Drug: Levodopa, Drug: CarbidopaParticipants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. |
| SCH 420814 100 mg→ SCH 420814 10 mg→Placebo | Experimental | Drug: SCH 420814 10 mg, Drug: SCH 420814 100 mg, Drug: Placebo, Drug: Levodopa, Drug: CarbidopaParticipants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. |
| Placebo→ SCH 420814 100 mg→SCH 420814 10 mg | Experimental | Drug: SCH 420814 10 mg, Drug: SCH 420814 100 mg, Drug: Placebo, Drug: Levodopa, Drug: CarbidopaParticipants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must have a diagnosis of idiopathic PD based on history, exam and any relevant laboratory tests
- Participants must have been treated with levodopa for one or more years
- Participants must have motor fluctuations that can be measured as a 10% change in tapping speed between "on" and "off" and concurrent motor Unified PD Rating Scale (UPDRS) must also show a 20% improvement when "on"
- Participants must have dyskinesia when "on" measured as at least 2 in one or more body parts on scale using 0 (absent) to 4 (severe) for four limbs, trunk, neck and face (total 7 body parts and 28 points)
- Participant must be free of any clinically significant disease that would interfere with the study evaluations
Key exclusion criteria (6 listed)
- Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating
- Participants with dementia (mini-mental state examination [MMSE] <23), hallucinations, confusion, major psychiatric disorders, and unstable medical conditions
- Participants with any stable surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- Participants with a positive screen for drugs of abuse
- Participants who are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| SCH 420814 10 mgone 10-mg capsule, orally, at hour 0 of treatment period | Drug | Placebo→ SCH 420814 100 mg→SCH 420814 10 mg, Placebo→SCH 420814 10 mg→SCH 420814 100 mg, SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg, SCH 420814 10 mg→SCH 420814 100 mg→Placebo, SCH 420814 100 mg→ SCH 420814 10 mg→Placebo, SCH 420814 100 mg→Placebo→ SCH 420814 10 mg |
| SCH 420814 100 mgsingle oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period | Drug | Placebo→ SCH 420814 100 mg→SCH 420814 10 mg, Placebo→SCH 420814 10 mg→SCH 420814 100 mg, SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg, SCH 420814 10 mg→SCH 420814 100 mg→Placebo, SCH 420814 100 mg→ SCH 420814 10 mg→Placebo, SCH 420814 100 mg→Placebo→ SCH 420814 10 mg |
| PlaceboPlacebo capsule, oral, at hour 0 of treatment period | Drug | Placebo→ SCH 420814 100 mg→SCH 420814 10 mg, Placebo→SCH 420814 10 mg→SCH 420814 100 mg, SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg, SCH 420814 10 mg→SCH 420814 100 mg→Placebo, SCH 420814 100 mg→ SCH 420814 10 mg→Placebo, SCH 420814 100 mg→Placebo→ SCH 420814 10 mg |
| Levodopalevodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours | Drug | Placebo→ SCH 420814 100 mg→SCH 420814 10 mg, Placebo→SCH 420814 10 mg→SCH 420814 100 mg, SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg, SCH 420814 10 mg→SCH 420814 100 mg→Placebo, SCH 420814 100 mg→ SCH 420814 10 mg→Placebo, SCH 420814 100 mg→Placebo→ SCH 420814 10 mg |
| Carbidopaone 25-mg table, orally, at hours 0, 2 and 4 of each treatment period | Drug | Placebo→ SCH 420814 100 mg→SCH 420814 10 mg, Placebo→SCH 420814 10 mg→SCH 420814 100 mg, SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg, SCH 420814 10 mg→SCH 420814 100 mg→Placebo, SCH 420814 100 mg→ SCH 420814 10 mg→Placebo, SCH 420814 100 mg→Placebo→ SCH 420814 10 mg |
Primary outcome
Mean Peak Dyskinesia Score
Time frame: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.
3 secondary outcomes
Mean Peak Finger Tapping Score
Time frame: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Mean Peak Tremor Score
Time frame: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Mean Peak Walking Speed
Time frame: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 1 study testing SCH 420814 10 mg, SCH 420814 100 mg and Levodopa 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 8 inclusion and 6 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 7 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 21 Jul 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?
Mean Peak Dyskinesia Score (time frame: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2018.