To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS).

Phase 1

• Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS); MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003147-19-GR
• Lead Sponsor: PALUPA Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-25
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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), Tecfidera/BG-12).
•Prior use in the 3 months preceding randomization, of cytokine therapy, glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments.
•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).
•Prior or concomitant use of Statins.
•Pregnancy or nursing.
•A clinically significant infectious illness within 30 days prior to randomization.
•Primary progressive, secondary progressive or progressive relapsing MS.
•Patients known to have a history of recent drug or alcohol abuse.
•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 NEUROASPIS PLP10® for 30 months.
•History of severe allergic or anaphylactic reactions or known specific nutritional hypersensitivity.

During on 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 continue to be medically followed for the intention to treat analyses purposes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS);Secondary Objective: Not applicable;Primary end point(s): Annual relapse rate (ARR);Timepoint(s) of evaluation of this end point: At enrolment, at entry baseline and at 6, 12, 18 and 24 (total 30 months including normalization) months on-treatment as well as at 6 months after the end of the study to confirm final EDSS score.Relapses will be evaluated and confirmed at any time they appear.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Time to confirmed disability progression. <br>2.The number of new or enlarging brain lesions (evaluated by MRI).<br>3.Quantity changes of inflammatory/anti-inflammatory markers in the blood.<br>;Timepoint(s) of evaluation of this end point: 1.At baseline, after 6 months for the confirmation, 6 months after the end of the study<br>2. At enrollment and at 24 months<br>3. at enrollment, baseline, 12 and 24-months