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

This study has been completed.
Sponsor:
Collaborator:
Advancell - Advanced In Vitro Cell Technologies, S.A.
Information provided by (Responsible Party):
Neurotec Pharma
ClinicalTrials.gov Identifier:
NCT01428726
First received: August 31, 2011
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: NT-KO-003
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Neurotec Pharma:

Primary Outcome Measures:
  • Efficacy of NT-KO-003 in patients with relapsing remitting MS patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline


Secondary Outcome Measures:
  • Efficacy of NT-KO-003 in relapsing remitting MS patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    efficacy measured as the cumulative number of new lesions (gadolinium enhanced lesions and T2 lesions) in all MRIs

  • Clinical efficacy of NT-KO-003 in relapsing remitting MS patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    clinical efficacy will be measured as relapse rates and EDSS scale

  • Safety of NT-KO-003 in patients with relapsing remitting MS patients [ Time Frame: six and a half months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 99
Study Start Date: June 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428726

Locations
Germany
Charité Universitätsmedizin
Berlin, Germany
Klinik und Poliklinik für Neurologie
Münster, Germany
Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
Wiesbaden, Germany
Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Josep Trueta
Girona, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario Puerta del Hierro
Madrid, Spain
Hospital Universitario 12 de Octubre
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
Sponsors and Collaborators
Neurotec Pharma
Advancell - Advanced In Vitro Cell Technologies, S.A.
Investigators
Principal Investigator: Pablo Villoslada, MD PhD Hospital Clinic i Provincial de Barcelona, Spain
  More Information

No publications provided

Responsible Party: Neurotec Pharma
ClinicalTrials.gov Identifier: NCT01428726     History of Changes
Other Study ID Numbers: NT-KO-003-2010-01
Study First Received: August 31, 2011
Last Updated: March 15, 2014
Health Authority: Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Neurotec Pharma:
NT-KO-003
RRMS
efficacy
safety
Phase IIa

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014