Relapsing-remitting multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Update as of 26/09/2018:
In case where there are changes and alteration of the local clinical practice guidelines, making difficult the enrolment due to difficulties to find patients i
Sponsors
Ministry of Commerce, Industry and Tourism (Cyprus)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures as of 31/03/2016: At 2 years the primary end points will be the annual relapse rate (ARR) 1. The study is designed to end 30 months after enrollment (plus 12-month washout period) and neurological and clinical assessments should be scheduled at entry baseline (6 months after enrollment, the end of normalization period) and at 6, 12, 18 and 24 months on-treatment. Another assessment should be scheduled 6 months after the end of the study if a patient is reported with an increased EDSS score during the 24th month assessment , otherwise at 12 months after the end of the study. 2. Patients should be examined within 48 hours after the onset of new neurological symptoms for the treating physician to confirm and record a relapse as per protocol Original primary outcome measures: At 2 years the primary end points will be the annual relapse rate (ARR) and the number of new or enlarging brain lesions (evaluated by MRI) 1. The study is designed to end 30 months after enrollment (plus 12-month washout period) and neurological and clinical assessments should be scheduled at entry baseline (6 months after enrollment, the end of normalization period) and at 6, 12, 18 and 24 months on-treatment. Another assessment should be scheduled 6 months after the end of the study if a patient is reported with an increased EDSS score during the 24th month assessment. 2. Patients should be examined within 48 hours after the onset of new neurological symptoms for the treating physician to confirm and record a relapse as per protocol. 3. MRI scans should be scheduled at enrollment and at the end (completion) of the study. 4. Number of T1 gadolinium-enhancing lesions, proportion of patients free from gadolinium-enhancing lesions, number of new or enlarged lesions on T2-weighted MRI scans, proportion of patients free from new or | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points at 2 years will be the time to confirmed disability progression and quantity changes of inflammatory/anti-inflammatory markers in the blood Time to confirmed disability progression is defined as an increase of 1.0 on the EDSS from a baseline score of 1.0 or more or an increase of 1.5 or more from a baseline score of 0.0, confirmed after 6 months, with an absence of an ongoing relapse at the time of assessment (progression cannot be confirmed during a relapse) and with no documented relapse during the 6-month period needed for the confirmation. Under the same conditions as previously discussed, the final EDSS score should also be confirmed 6 months after the end of the study. Blood samples should be collected at enrollment, baseline, 12 and 24 months (total of 30 months including normalization) for specific pharmacodynamic/pharmacokinetic experimental investigations (markers in the blood). 1. Evaluation of the hematological (full blood count) and biochemical analyses at enrollment, baseline (6 months after enrollment), 12 months and 24 months on treatment and compared to enrollment and baseline. 2. Compare changes of inflammatory markers, cytokines, chemokines, adhesion molecules and lipid metabolite markers in plasma at enrollment, baseline, 12, 24 months on treatment and compared to enrollment and baseline. 3. Specific antioxidant vitamin counts in serum at enrollment, baseline, 12, 24 months on treatment compared to enrollment and baseline. 4. Changes of antioxidant activity and fatty acids in the serum and red blood cells at enrollment, baseline, 12, 24 months on treatment and compared to enrollment and baseline. Safety adverse events: Hematological (full blood count) and biochemical analyses at enrolment, baseline, 12 months and at study completion. Serious adverse events are defined as those tha | — |
Countries
Cyprus, Greece
Outcome results
None listed