Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2019-05-28

Brief Summary

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This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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K0706

K0706 will be administered once a day

Group Type EXPERIMENTAL

K0706

Intervention Type DRUG

Once a day administration after fast

Placebo

Placebo will be administered once a day

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Once a day administration after fast

Interventions

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K0706

Once a day administration after fast

Intervention Type DRUG

Placebo

Once a day administration after fast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. 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
3. Male or female aged 18 to 65 years (both inclusive)
4. Diagnosed with Parkinson's disease

Exclusion Criteria

1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
2. Diagnosis of Parkinson's disease Dementia (probable, possible)
3. Presence of severe dyskinesias
4. History of brain surgery for Parkinson's disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No