Status:
COMPLETED
Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
Greek Alzheimer's Association and Related Disorders
Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com)
Conditions:
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To date, no drug therapy has been approved for primary (PPMS) \& secondary (SPMS) progressive multiple sclerosis. The urgent need to find new therapies - if possible with minimal side effects - led us...
Detailed Description
Study Type: Randomized Clinical Trial. Primary Purpose: Prevention OBJECTIVES OF THE TRIAL The objectives of this study are:To investigate the efficacy of Early Harvest EVOO as a disease course modify...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of primary (PPMS) or secondary (SPMS) progressive multiple sclerosis
- EDSS≥ 5
- No response to any given treatment for MS or interruption due to side effects
- Progressive aggravation in the disease's progression estimated by: deterioration in EDSS-plus disability scale, Timed 25-Foot Walk or 9-hole peg test.
- Progressive aggravation in the disease's progression estimated by: new lesions in MRI scan and neuropsychological tests
- Progressive aggravation in patient's neuropsychological status
- Progressive aggravation in patient's Quality of life, estimated with MuSIQol - Greek 3.01 MS and SF-36
- Years of education: \>= 5
- Proficient language fluency
- Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
- Compliance
Exclusion
- Enrollment in other trials or studies not compatible with MSOIL
- Visual and auditory acuity inadequate for neuropsychological testing
- History of significant other neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
- Use of forbidden medications (listed below)
- Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
- Any significant or uncontrolled medical condition or treatment-emergent
- Clinically significant laboratory abnormality
- Medications across the study
- Excluded Medication:
- Immunosuppressant or immunomodulating agents, corticosteroids, or investigational drugs within 3 months of study initiation
- Antibiotics in general, at least one month prior assessment of specific inflammatory markers (faecal levels of calprotectin, metabolomic profile, gut microbiota)
- Use of neuroleptics or within 4 weeks of screening
- Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).
Key Trial Info
Start Date :
November 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04120675
Start Date
November 9 2018
End Date
June 6 2021
Last Update
July 9 2021
Active Locations (1)
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1
A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)
Thessaloniki, Macedonia, Greece, 546 36