Parkinson's DiseaseNCT02028858
Cannabis and Parkinson's Disease Tremor: A Natural History Study
An observational study of Parkinson's Disease, run by Bastyr University at 1 site in United States.
Trial summary
This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinics; Washington State Parkinson's Disease Registry
Who may be able to join
- 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
Who cannot join
- Presence of active infection within 5 days prior to enrollment
- Presence of unusual stressor within 5 days prior to enrollment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.
Read the 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.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in tremor as measured by Opal movement sensor
Measured: Upon enrollment, ongoing for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie K Mischley, ND, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028858
- Sponsor's protocol ID
- 13A-1339
- Status last verified
- Jun 2016
- First submitted
- 6 Jan 2014
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis and Parkinson's Disease Tremor: A Natural History Study
- ClinicalTrials.gov ID
- NCT02028858
- Acronym / sponsor ID
- 13A-1339
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinics; Washington State Parkinson's Disease Registry
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of active infection within 5 days prior to enrollment
- Presence of unusual stressor within 5 days prior to enrollment
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent reduction in tremor as measured by Opal movement sensor
Time frame: Upon enrollment, ongoing for 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie K Mischley, ND principal investigator
Bastyr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Bastyr University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in tremor as measured by Opal movement sensor (time frame: Upon enrollment, ongoing for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.