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

NCT ID: NCT01428726

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-01-31

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, subjects will be randomized to three treatments arms: placebo, NT-KO-003 low dose or NT-KO-003 high dose. Treatment will continue daily during 6 months. A MRI and a clinical evaluation will be performed monthly. Safety will be assessed during the 6 months treatment and until 15 days after the finalization of the treatment.

Patients will be allowed to continue in the same arm of the study, in a blinded way, until the study finalizes as optional extension treatment. Patient will sign the Extension Informed Consent and a MRI will be performed for those patients still in treatment after 12 months of the inclusion in the core study (visit 0).

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

NT-KO-003

Intervention Type: DRUG

NT-KO-003 is a coated tablet, administered once a day

NT-KO-003 low dose

Group Type: EXPERIMENTAL

NT-KO-003

Intervention Type: DRUG

NT-KO-003 is a coated tablet, administered once a day

NT-KO-003 high dose

Group Type: EXPERIMENTAL

NT-KO-003

Intervention Type: DRUG

NT-KO-003 is a coated tablet, administered once a day

Interventions

NT-KO-003

NT-KO-003 is a coated tablet, administered once a day

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advancell - Advanced In Vitro Cell Technologies, S.A.

INDUSTRY

Sponsor Role: collaborator

Neurotec Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Villoslada, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic i Provincial de Barcelona, Spain

Locations

Charité Universitätsmedizin

Berlin, , Germany

Klinik und Poliklinik für Neurologie

Münster, , Germany

Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH

Wiesbaden, , Germany

Hospital Germans Trias i Pujol

Badalona, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Vall d'Hebrón

Barcelona, , Spain

Hospital Universitari Josep Trueta

Girona, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Hospital Universitario Puerta del Hierro

Madrid, , Spain

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Universitario La Fe

Valencia, , Spain

Hospital Xeral Vigo

Vigo, , Spain

Countries

Germany; Spain

Other Identifiers

NT-KO-003-2010-01

Identifier Type: -

Identifier Source: org_study_id