MINERAL (Magnetic-resonance Image of Nutraceutical Efficacy on Relapsing-ms Autoimmune Lesions) study: a novel nutraceutical formula NEUROASPIS PLP10® for the treatment of relapsing-remitting multiple sclerosis

Phase 3

Completed

• Conditions: Relapsing-remitting multiple sclerosis; Nervous System Diseases; Multiple sclerosis

• Registration Number: ISRCTN06166891
• Lead Sponsor: Ministry of Commerce, Industry and Tourism (Cyprus)

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23599375 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36353267/ (added 11/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-19
• Study Completion: 2018-12-31
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Men and women
2. Aged between 18 and 55 years
3. Diagnosis of relapsing remitting multiple sclerosis (RRMS) according to revised McDonald criteria
4. A score of 0.0 to 5.0 on the Expanded Disability Status Scale (EDSS)
5. At least one medically documented relapse within the 18 months before enrolment
6. Cranial MRI scan demonstrating lesion(s) consistent with MS
7. On interferon beta (IFN-ß) treatment for the last 6 continuous months or more

Note: If a clinical documented relapse (see primary outcomes) is reported during the 'normalization' period the entry baseline EDSS for that patient will be reported as the EDSS score documented at least 4 weeks after the last relapse during this period.

Exclusion Criteria

1. Prior immunosuppressants or monoclonal antibodies therapy (prior or concomitant use of cladribine, mitoxantrone, copaxone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, fingolimod or natalizumab [Tysabri]) or Tecfidera/BG-12)
3. Prior use in the 3 months preceding randomization of cytokine therapy, glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments
3. Pregnancy or nursing
4. A clinically significant infectious illness within 30 days prior to randomization
5. Primary progressive, secondary progressive or progressive relapsing MS
6. Patients known to have a history of recent drug or alcohol abuse
7. Any severe disease other than MS compromising organ function, meaning: history of or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, renal and/or other major disease, that in the opinion of the investigator would preclude the administration of PLP10 for 30 months.
8. History of severe allergic or anaphylactic reactions or known specific nutritional hypersensitivity.

As of 31/03/2016 the following exclusion criteria have been added:
9. Consumption of any additional food supplement formula (prior use in the 3 months preceding randomization, of any type of vitamin including vitamin D, or 6 months preceding randomization, of any form of polyunsaturated fatty acid (PUFA), or concomitant use of these treatments)
10. Prior or concomitant use of statins

Note: During intervention treatment it is strongly suggested for the patients to continue only on the interferon beta treatment. If a patient changes therapy to immunosuppressant or monoclonal antibody or fingolimode or any other treatment on physicians? decision then he/she will be considered as a drop-out, but will continue to be medically followed for the purpose of the intention-to-treat analyses.

Study & Design

• Study Type: Interventional
• Study Design: Not specified