Multiple sclerosis therapy with transdermal myelin peptide stimulation.

Phase 1

• Conditions: relapsing-remitting multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002180-33-PL
• Lead Sponsor: Centrum Neurologii Krzysztof Selmaj

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-14
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

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

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: every patient visit;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.<br><br>;Secondary Objective: Secondary objectives :<br>- cumulative number of gadolinium positive changes in MRI<br>- new / enlarging changes in the MRI T2 sequence <br>- number of new changes in the MRI T1 sequence <br>- change in MTR factor<br>;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.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - cumulative number of gadolinium positive changes in MRI<br>- new / enlarging changes in the MRI T2 sequence <br>- number of new changes in the MRI T1 sequence <br>- change in MTR factor<br>;Timepoint(s) of evaluation of this end point: 12,24,36,48,60,72,84,96 week