NCT02028858

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

January 6, 2014

Last Update Submit

June 23, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Percent reduction in tremor as measured by Opal movement sensor

    Upon enrollment, ongoing for 14 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinics; Washington State Parkinson's Disease Registry

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bastyr University

Kenmore, Washington, 98028, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Laurie K Mischley, ND

    Bastyr University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 7, 2014

Study Start

November 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 27, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)