Quick Info
Status
Currently Recruiting
Estimated Enrollment
10000
Phase
N/A
Treatment Type
Drug: Cannabis, Medical
Trial Type
Cohort, Prospective
Primary Investigator
Ryan O Lakin, MD JD
Contact Information
Locations
OMNI Medical Services , Boca Raton, 33433
OMNI Medical Services , Bradenton, 34209
OMNI Medical Services , Fort Lauderdale, 33308
OMNI Medical Services , Fort Myers, 34135
OMNI Medical Services , Gainesville, 36201
OMNI Medical Services , Merritt Island, 32952
OMNI Medical Services , Miami, 33137
OMNI Medical Services , Ocoee, 34761
OMNI Medical Services , Pensacola, 32505
OMNI Medical Services , Pompano Beach, 33060
OMNI Medical Services , Tampa, 33614
OMNI Medical Services , Wesley Chapel, 33544
OMNI Medical Services , Beechwood, 44122
OMNI Medical Services , Bowling Green, 43402
OMNI Medical Services , Sandusky, 44870
OMNI Medical Services , Toledo, 43604
OMNI Medical Services , Toledo, 43611
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
N/A
Months Since Onset
Number of months since first symptoms of ALS.
N/A
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
N/A
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Update Notes
No significant updates
7/1/2019
Trial added
5/13/2019

Other Information

Purpose
This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
Eligibility
7 Years and older, all genders, accepting healthy volunteers
Details
Medical cannabis has been legal in parts of the USA since 1996, with the stated intention of reducing pain (both acute and chronic) as well as for treatment of multiple other conditions. The original implementation of medical cannabis in the USA was implemented in California as a compassionate measure to treat the HIV/AIDS epidemic. Additional studies have shown promising outcome for patients with multiple sclerosis, seizures, cancer, and other chronic conditions. However, there have been few comprehensive studies that have actually measured whether cannabis is an effective treatment for pain reduction. There is an absence of multistate, multicenter clinical studies with cannabis as medicine, not only in the USA but globally. With the expansion of medical cannabis into more than 38 states in the US, this type of clinical study is now feasible. This study will utilize an anonymous novel online questionnaire to determine study participants' qualifying condition(s) for medical cannabis use, cannabis ingestion method, frequency of use, prescription drug use, and demographic information. Secondary factors will include evaluation of pain control, quality of life metrics, any adverse side effects from cannabis use, as well as changes in adjunctive treatments. Patients will be given medical cannabis recommendations and certifications commensurate with the state law in which the encounter occurs. The variations in mechanisms between the states for recommending, registering, certifying, and developing mandated treatment plans or doses will be adhered to; however, variations in state law and cannabis programs should not cause variation in the study design because the end-result is still the same with patients being treated with medical cannabis.
Collaborator(s)
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News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT03944447 (First Published: 5/9/2019)