Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02006290 |
Recruitment Status :
Completed
First Posted : December 10, 2013
Last Update Posted : October 2, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Drug: PF-06412562 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: PF-06412562
single oral split dose 30+20 mg QD |
Placebo Comparator: 2 |
Drug: Placebo
tablet, matching placebo, QD |
- Finger tapping speed [ Time Frame: 12 hours ]maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 5,8,12, 24 hours ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
- Apparent Volume of Distribution (Vz/F) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
- Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
- Mean Residence Time (MRT) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
- Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 hours ]C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
- Daily L-dopa dose between 300 and 1200 mg.
- MBRS score >1.
Exclusion Criteria:
- Surgical intervention for Parkinson's disease.
- History of troublesome dyskinesias.
- Any significant AXIS I psychiatric disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006290
United States, Florida | |
Pfizer Investigational Site | |
Aventura, Florida, United States, 33180 | |
Pfizer Investigational Site | |
Baco Raton, Florida, United States, 33486 | |
Pfizer Investigational Site | |
South Miami, Florida, United States, 33143 | |
United States, Michigan | |
Pfizer Investigational Site | |
Bingham Farms, Michigan, United States, 48025 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Raleigh, North Carolina, United States, 27612 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02006290 |
Other Study ID Numbers: |
B7441003 |
First Posted: | December 10, 2013 Key Record Dates |
Last Update Posted: | October 2, 2015 |
Last Verified: | September 2015 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |