relapsing-remitting multiple sclerosis
Conditions
Interventions
Product Name: SMderpept
Pharmaceutical Form: Powder for cutaneous solution
INN or Proposed INN: PLP peptide
Current Sponsor code: PLP peptide
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Centrum Neurologii Krzysztof Selmaj
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The signing of informed consent to participate in the study Women and men aged 18-60 years RR diagnosis of MS according to the McDonald criteria 2010 State disability by EDSS 0 to 5.5 At least one relapse in the 12 months prior to screening Neurologically stable during the 30 days prior to screening 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
Exclusion criteria: Patients with diagnosis of SP MS and PP MS. Pregnant patients Patients with active immune system diseases, rheumatoid arthritis, scleroderma, Crohn's disease, etc. Patients with bone marrow dysfunction, significant anemia, leukopenia, neutropenia, thrombocytopenia Patients with active infection, bacterial, fungal or viral Patients with AIDS Patients with a history of syphilis, tuberculosis, hepatitis B or C Patients vaccinated with a live or attenuated vaccine within 2 months prior to screening Patients treatment with steroids or ACTH during the 30 days prior to screening Patients treated in the past with interferon beta who discontinued treatment due to inefficiency Patients with natalizumab treatment during the 6 months prior to screening Patients treated with mitoxantrone 2 years before screening Patients treated with fingolimod or dimethyl fumarate 2 months prior to screening Patients with a history of cancer other than basal cell carcinoma Patients with significant underlying cardiovascular, respiratory, gastrointestinal tract, kidney. Patients who are unable to undergo MRI Patients with a history of hyperactivity / allergy skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The demonstration that myelin MBP85-99, MOG 35-55 PLP139-151 peptide mixture reduces the amount of relapses as compared to treatment with interferon beta 1A. ;Secondary Objective: Secondary objectives : - cumulative number of gadolinium positive changes in MRI - new / enlarging changes in the MRI T2 sequence - number of new changes in the MRI T1 sequence - change in MTR factor ;Primary end point(s): The demonstration that myelin MBP85-99, MOG 35-55 PLP139-151 peptide mixture reduces the amount of relapses as compared to treatment with interferon beta 1A. ;Timepoint(s) of evaluation of this end point: every patient visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - cumulative number of gadolinium positive changes in MRI - new / enlarging changes in the MRI T2 sequence - number of new changes in the MRI T1 sequence - change in MTR factor ;Timepoint(s) of evaluation of this end point: 12,24,36,48,60,72,84,96 week | — |
Countries
Poland
Contacts
Public Contactcontact point information
Centrum Neurologii Krzysztof Selmaj
Outcome results
None listed