Status:
COMPLETED
A Phase IIa Study of NT-KO-003 for Multiple Sclerosis
Lead Sponsor:
Neurotec Pharma
Collaborating Sponsors:
Advancell - Advanced In Vitro Cell Technologies, S.A.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a Phase IIa study, double blind, placebo Controlled, Multicenter Study that will involve up to 99 patients with relapsing remitting multiple sclerosis. After signing the informed consent form...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01428726
Start Date
June 1 2011
End Date
January 1 2014
Last Update
March 18 2014
Active Locations (17)
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1
Charité Universitätsmedizin
Berlin, Germany
2
Klinik und Poliklinik für Neurologie
Münster, Germany
3
Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
Wiesbaden, Germany
4
Hospital Germans Trias i Pujol
Badalona, Spain