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

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

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.

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: NT-KO-003

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).

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin
  • Münster, Germany
    • Klinik und Poliklinik fur Neurologie
  • Wiesbaden, Germany
    • Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
• Spain
  • Badalona, Spain
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Clinic I Provincial
  • Barcelona, Spain
    • Hospital Vall d'Hebron
  • Girona, Spain
    • Hospital Universitari Josep Trueta
  • Madrid, Spain
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario La Princesa
  • Madrid, Spain
    • Hospital Universitario Puerta del Hierro
  • Málaga, Spain
    • Hospital Regional Universitario Carlos Haya
  • Santiago de Compostela, Spain
    • Complexo Hospitalario Universitario De Santiago
  • Valencia, Spain
    • Hospital Universitario La Fé
  • Vigo, Spain
    • Hospital Xeral Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: NT-KO-003; NT-KO-003 is a coated tablet, administered once a day
Experimental: NT-KO-003 low dose	Drug: NT-KO-003; NT-KO-003 is a coated tablet, administered once a day
Experimental: NT-KO-003 high dose	Drug: NT-KO-003; NT-KO-003 is a coated tablet, administered once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clinical efficacy of NT-KO-003 in relapsing remitting MS patients	clinical efficacy will be measured as relapse rates and EDSS scale	6 months
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

Collaborators and Investigators

• Sponsor: Neurotec Pharma
• Collaborators: Advancell - Advanced In Vitro Cell Technologies, S.A.
• Investigators: Principal Investigator: Pablo Villoslada, MD PhD, Hospital Clinic i Provincial de Barcelona, Spain

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: September 2, 2011
• First Posted (Estimate): September 5, 2011

Study Record Updates

• Last Update Posted (Estimate): March 18, 2014
• Last Update Submitted That Met QC Criteria: March 15, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: safety; RRMS; efficacy; NT-KO-003; Phase IIa
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: NT-KO-003-2010-01