Multiple SclerosisNCT02898974
Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Colorado State University at 1 site in United States.
Trial summary
Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Medical Marijuana
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults diagnosed with Multiple Sclerosis.
Who may be able to join
- Medically diagnosed with MS,
- 30-60 years of age,
- Moderate disability (Patient Determined Disease Steps score 2-6).
Who cannot join
- Relapse with the last 60 days,
- High risk for cardiovascular disease (American College of Sports Medicine risk classification),
- Changes in disease modifying medications within the last 45 days,
- Concurrent neurological/neuromuscular disease,
- Hospitalization within the last 90 days,
- Inability to understand/sign informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Exercise Science
Fort Collins, Colorado, 80523
About this study
Official title: Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis: An Observational Case-control Study
Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Several previous studies have suggested people with MS using medical marijuana have lower levels of physical disability and improved walking abilities. A major limitation of these previous studies is that the investigators used subjective measures of motor function. In this proposed observational case-control study the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.
Read the detailed description
To investigate the effects of medical marijuana usage on physical function the investigators will employ an observational case-control design. Cases (MS medical marijuana users) will be compared to age, sex, and disease duration matched controls (MS non-cannabis users).
- Conditions
- Multiple Sclerosis
- Being tested
- Medical Marijuana
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical MarijuanaBehavioural
To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design
| Study group | Role | What they receive |
|---|---|---|
| Regular Medical Marijuana users | People with MS that are regular Medical Marijuana users Receives: Behavioral: Medical Marijuana | |
| Non Users of Medical Marijuana | People with MS that are non users of Medical Marijuana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Strength decline during fatiguing muscle contraction measured with force transducer
Measured: Through study completion, an average of 6 months.
Muscle Strength
Maximal muscle strength measured with force transducer
Measured: Through study completion, an average of 6 months.
Postural Stability
Timed up and go
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- William R. Shaffer, M.D.
- Responsible party
- Principal investigator, Thorsten Rudroff, Colorado State University
- Investigators
- Thorsten Rudroff, Ph.D., Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898974
- Sponsor's protocol ID
- 16-6685HH
- Status last verified
- Feb 2019
- First submitted
- 6 Sep 2016
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis: An Observational Case-control Study
- ClinicalTrials.gov ID
- NCT02898974
- Acronym / sponsor ID
- 16-6685HH
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- William R. Shaffer, M.D.
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Several previous studies have suggested people with MS using medical marijuana have lower levels of physical disability and improved walking abilities. A major limitation of these previous studies is that the investigators used subjective measures of motor function. In this proposed observational case-control study the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.
Detailed description
To investigate the effects of medical marijuana usage on physical function the investigators will employ an observational case-control design. Cases (MS medical marijuana users) will be compared to age, sex, and disease duration matched controls (MS non-cannabis users).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Medical Marijuana users | – | Behavioral: Medical MarijuanaPeople with MS that are regular Medical Marijuana users |
| Non Users of Medical Marijuana | – | –People with MS that are non users of Medical Marijuana |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults diagnosed with Multiple Sclerosis.
Key inclusion criteria (3 listed)
- Medically diagnosed with MS,
- 30-60 years of age,
- Moderate disability (Patient Determined Disease Steps score 2-6).
Key exclusion criteria (6 listed)
- Relapse with the last 60 days,
- High risk for cardiovascular disease (American College of Sports Medicine risk classification),
- Changes in disease modifying medications within the last 45 days,
- Concurrent neurological/neuromuscular disease,
- Hospitalization within the last 90 days,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical MarijuanaTo investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design | Behavioural | Regular Medical Marijuana users |
Primary outcome
Fatigue
Time frame: Through study completion, an average of 6 months.
Strength decline during fatiguing muscle contraction measured with force transducer
Muscle Strength
Time frame: Through study completion, an average of 6 months.
Maximal muscle strength measured with force transducer
Postural Stability
Time frame: Through study completion, an average of 6 months.
Timed up and go
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Thorsten Rudroff, Ph.D. principal investigator
Colorado State 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 Multiple Sclerosis, run by Colorado State 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 3 inclusion and 6 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 5 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fatigue (time frame: Through study completion, an average of 6 months.). The study lists 3 primary outcomes in all. 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 5 Feb 2020.