Cannabis and Parkinson's Disease Tremor: A Natural Histor... | NCT02028858

Studies
Cannabis and Parkinson's Disease Tremor: A Natural History Study

NCT02028858

Sponsor

Bastyr University

Status

Completed

Last Update Posted

Jun 27, 2016Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jan 6, 2014

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2016

Last Update Posted Date

Jun 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.

Detailed Description

Ten individuals with Parkinson's disease (PD) and tremor who use Cannabis were observed for two weeks. Individuals were asked to keep a journal of Cannabis use (form, delivery method, amount) and wear an accelerometer on the wrist with the dominant tremor. Analyses will be performed to describe whether Cannabis use affects PD tremor following use.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent reduction in tremor as measured by Opal movement sensor		Upon enrollment, ongoing for 14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Parkinson's Disease
Presence of PD-related tremor
Currently using Cannabis for management of tremor
Obtaining Cannabis in accordance with Washington State law
Willing to log activities and experiences
Willing to wear a motion sensor
Able to attend 2 on-site visits

Exclusion Criteria:

Presence of active infection within 5 days prior to enrollment
Presence of unusual stressor within 5 days prior to enrollment
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary Care Clinics; Washington State Parkinson's Disease Registry

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurie K Mischley, ND	Bastyr University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bastyr University		Kenmore	Washington	98028	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided