A Phase IIa Study of NT-KO-003 for Multiple Sclerosis

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of relapsing remitting multiple sclerosis, comparing two doses versus placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurotec Pharma
• Collaborator: Advancell - Advanced In Vitro Cell Technologies, S.A.

Criteria

Inclusion Criteria

• Patients who meet the diagnosis criteria for MS according to guidelines provided by McDonald et al (1)

• Patients who meet the diagnosis criteria for RRMS

• Patients with clinical disability measured by EDSS score between 0 and 5.0 inclusive

• Patients who present at least 1 relapse in the previous 2 years or presence of at least 1 gadolinium-enhanced lesion in the previous 1 year

• Patients aged between 18 to 55 years old, either gender

Exclusion Criteria

• Patients who are candidates for treatment with drugs modifying the course of the disease according to the criteria of the Regulatory Agencies in each country, unless the patient refuses to initiate such therapy or decide to postpone the start of this therapy

• Patients with relapse in the 30 days period before baseline visit

• Patients in treatment with NT-KO-003

• Medical conditions such as hypotension, insulinoma, hyperuricemia

• Patients with Diabetes defined by ADA criteria (2)

• Other conditions: drug abuse, inability to consent, or inability to perform all the procedures for the Clinical Trial

• Contraindications for MRI studies: claustrophobia, heart pacemaker or any other condition that would preclude proximity to strong magnetic field

• Contraindications for treatment with NT-KO-003 or excipients: allergies, hypersensitivity

• Patients with known allergy or with contraindications to the administration of intravenous gadolinium-based agents (chronic or acute renal failure according to The Renal Association or NICE guidelines (3))

• Corticosteroid therapy in the last month

• Interferon-beta or Glatiramer acetate therapy in the last 3 months

• Natalizumab therapy in the last 6 months

• Patients treated with chemotherapy (Mitoxantrone, Azathioprine, Cyclophosphamide, Cladribine, Methotrexate) or monoclonal antibodies that deplete populations of cells (rituximab, alemtuzumab, ocrelizumab, daclizumab) in the last 12 months or have entered in previous trials with treatments in development in the last 3 months

• Patients participating in another Clinical Trial at the moment of the screening visit

• Patient who had received a liver transplantation or candidates for liver transplantation

• Positive pregnancy test, breast feeding women or of childbearing potential not using highly effective methods of contraception

• Male patients that do not follow adequate contraceptive measurements

• Fingolimod therapy in the last 6 months