Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
1 other identifier
interventional
60
1 country
5
Brief Summary
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 parkinson-disease
Started Mar 2017
Typical duration for phase_1 parkinson-disease
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedStudy Start
First participant enrolled
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2019
CompletedMarch 31, 2020
March 1, 2020
2.2 years
November 18, 2016
March 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
4 weeks
Secondary Outcomes (3)
Peak plasma concentration
4 weeks
Area under the plasma concentration versus time curve
4 weeks
Time of observed peak plasma concentration
4 weeks
Study Arms (2)
K0706
EXPERIMENTALK0706 will be administered once a day
Placebo
EXPERIMENTALPlacebo will be administered once a day
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study
- Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up
- Male or female aged 18 to 65 years (both inclusive)
- Diagnosed with Parkinson's disease
You may not qualify if:
- Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
- Diagnosis of Parkinson's disease Dementia (probable, possible)
- Presence of severe dyskinesias
- History of brain surgery for Parkinson's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
SPARC Site 03
Long Beach, California, 90806, United States
SPARC Site 05
Panorama City, California, 91402, United States
SPARC Site 01
DeLand, Florida, 32720, United States
SPARC Site 02
Orlando, Florida, 32806, United States
SPARC Site 04
Raleigh, North Carolina, 27612, United States
Related Publications (1)
Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.
PMID: 40680102DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2016
First Posted
November 21, 2016
Study Start
March 30, 2017
Primary Completion
May 28, 2019
Study Completion
May 28, 2019
Last Updated
March 31, 2020
Record last verified: 2020-03