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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03172741 |
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Date of registration:
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25/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis
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Scientific title:
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The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03172741 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Contacts
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Name:
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Thorsten Rudroff, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Colorado State University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Medically diagnosed with MS
- Age range 21-74 years of age
- Moderate disability (Patient Determined Disease Steps score 2-6)
- All participants must have a medical (red) card for medical marijuana use to treat
their MS symptoms (such as neuropathic pain and spasticity), or currently be in the
process of applying for a red card and be able to provide the prescription from their
doctor.
Exclusion Criteria:
- Previous use of marijuana
- A relapse of disease symptoms in the last 60 days
- A condition unrelated to MS that would exacerbate fatigue, such as anemia,
hypothyroidism, shiftwork-related fatigue, B12 deficiency, major sleep disorder, or
major depressive disorder
- Medical diagnosis or condition that makes participating in exercise training
dangerous, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV,
cancer (other than treated basal cell cancer), other neurological disorders
- History of heart attack or current diagnosis of cardiovascular disease
- History of seizure disorders (or on medications known to lower seizure threshold),
hydrocephalus (buildup of fluid in the brain), or diabetes
- Alcohol dependence or abuse (>2 drinks/day), or present history (last six months) of
drug abuse
- History of significant traumatic brain injury or hydrocephalus
- Pregnancy
- Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state
- Current participation in another research study that involves experiments on drugs or
interventions which may influence motor and cognitive function.
Age minimum:
21 Years
Age maximum:
74 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Medical Marijuana
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Drug: Placebo
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Primary Outcome(s)
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9 hole peg test
[Time Frame: 1 year]
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Leg Strength
[Time Frame: 1 year]
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Fatigue Severity Scale
[Time Frame: 1 year]
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Quality of Life
[Time Frame: 1 year]
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25 foot walk test
[Time Frame: 1 year]
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Becks Depression Inventory
[Time Frame: 1 year]
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Paced Auditory Serial Addition Test
[Time Frame: 1 year]
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Pain Effect Scale.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Lean Body Mass
[Time Frame: 1 year]
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Fat Mass
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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