Safety of cannabidiol in Parkinson’s disease patient

Phase 1

• Conditions: Safety and tolerability; saftey

• Registration Number: TCTR20191204004
• Lead Sponsor: Prasat Neurological Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-04
• Study Completion: 2020-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Stable Parkinson's disease patient with unchanged medications for at least 1 month before enrolling to the trial
2) Parkinson's disease patient who tested for memory(TMSE)not more than 1 year and the score is not less than 23 bofore enrolling to the trial
3) Parkinson's disease patient without cannabidiol usage within 1 month before enrolling to the trial
4) Parkinson's disease patient with the age of over 18 years old
5) Willing and able to give informed consent

Exclusion Criteria

1) Parkinson's disease patient with
-Psychiatric disease
-dementia
-cardiovascular disease
-arrhythmia
-liver disease or abnormal liver function test(AST orALT more than 40 U/L
-epilepsy
2)Parkinson's disease patient who is pregnant or lactating
3)Parkinson's disease patient who is not willing to participate in this trial

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Cannabidiol in Parkinson’s disease patient at 6 months after end of the intervention Adverse events grading

Secondary Outcome Measures

Name	Time	Method
Efficacy of Cannabidiol in Parkinson’s disease patient 1 day after end of the intervention Unified Parkinson Disease Rating Scale Part III