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

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Placebo; Drug: K0706

Study type: Interventional

Funder types: Industry

Identifiers

NCT02970019

CLR_16_27

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

K0706

Experimental group

Description:

K0706 will be administered once a day

Treatment:

Drug: K0706

Placebo

Experimental group

Description:

Placebo will be administered once a day

Treatment:

Drug: Placebo