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

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2015-003147-19-GR
• Date of registration: 25/05/2016
• Prospective Registration: Yes
• Primary sponsor: PALUPA Medical Ltd
• Public title: To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS).
• Scientific title: Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety. - Efficacy and Safety study of NEUROASPIS PLP10® versus placebo
• Date of first enrolment: 18/07/2016
• Target sample size: 220
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003147-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Greece

Contacts

• Name: CLINICAL TRIAL INFORMATION
• Affiliation: BECRO

• Name: CLINICAL TRIAL INFORMATION
• Affiliation: BECRO

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: NEUROASPIS PLP10®
Pharmaceutical Form: Oral liquid
INN or Proposed INN: FISH OIL,RICH IN OMEGA 3 ACIDS
Other descriptive name: FISH OIL, RICH IN OMEGA-3-ACIDS
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 42.1-
INN or Proposed INN: BORAGE OIL 20% GLA
CAS Number: 8000051-62-9
Other descriptive name: BORAGE OIL
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 43.7-
INN or Proposed INN: beta-Carotene
Other descriptive name: BETACAROTENE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.04-
INN or Proposed INN: Gamma-tocopherol
CAS Number: 54 28 4
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 4.2-
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Not applicable

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.

Primary end point(s): Annual relapse rate (ARR)

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 Outcome(s)

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
2. At enrollment and at 24 months
3. at enrollment, baseline, 12 and 24-months

Secondary end point(s): 1. Time to confirmed disability progression.
2. The number of new or enlarging brain lesions (evaluated by MRI).
3. Quantity changes of inflammatory/anti-inflammatory markers in the blood.

Secondary ID(s)

BECRO/MINERALstudy

Source(s) of Monetary Support

PALUPA Medical Ltd