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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428726
• Other study ID #: NT-KO-003-2010-01
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2011
• Last updated: March 15, 2014
• Start date: June 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Neurotec Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin	Berlin
Germany	Klinik und Poliklinik für Neurologie	Münster
Germany	Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH	Wiesbaden
Spain	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

Sponsors (2)

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

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Efficacy of NT-KO-003 in relapsing remitting MS patients	efficacy measured as the cumulative number of new lesions (gadolinium enhanced lesions and T2 lesions) in all MRIs	6 months	No
Secondary	Clinical efficacy of NT-KO-003 in relapsing remitting MS patients	clinical efficacy will be measured as relapse rates and EDSS scale	6 months	No
Secondary	Safety of NT-KO-003 in patients with relapsing remitting MS patients	safety will be measured as the incidence of adverse events and serious adverse events (incidence, causality, and severity) related to treatment with NT-KO-003	six and a half months	Yes