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

NCT01428726 | Completed Phase 2

• 1 other identifier: NT-KO-003-2010-01
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 17

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

NT-KO-003; RRMS; efficacy; safety; Phase IIa

Outcome Measures

Primary Outcomes (1)

• Efficacy of NT-KO-003 in patients with relapsing remitting MS patients

  efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline

  6 months

Secondary Outcomes (3)

• Efficacy of NT-KO-003 in relapsing remitting MS patients

  6 months

• Clinical efficacy of NT-KO-003 in relapsing remitting MS patients

  6 months

• Safety of NT-KO-003 in patients with relapsing remitting MS patients

  six and a half months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: NT-KO-003

NT-KO-003 low dose

EXPERIMENTAL

Drug: NT-KO-003

NT-KO-003 high dose

EXPERIMENTAL

Drug: NT-KO-003

Interventions

NT-KO-003 DRUG

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

NT-KO-003 high dose; NT-KO-003 low dose; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurotec Pharma: lead
• Advancell - Advanced In Vitro Cell Technologies, S.A.: collaborator

Study Sites (17)

Charité Universitätsmedizin

Berlin, Germany

Location

Klinik und Poliklinik für Neurologie

Münster, Germany

Location

Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH

Wiesbaden, Germany

Location

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital Clinic i Provincial

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Vall d'Hebrón

Barcelona, Spain

Location

Hospital Universitari Josep Trueta

Girona, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital Universitario Puerta del Hierro

Madrid, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Xeral Vigo

Vigo, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pablo Villoslada, MD PhD

  Hospital Clinic i Provincial de Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 5, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

ES (14); DE (3)