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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01428726
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
Advancell - Advanced In Vitro Cell Technologies, S.A.
Information provided by (Responsible Party):
Neurotec Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: NT-KO-003 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of NT-KO-003 in patients with relapsing remitting MS patients [ Time Frame: 6 months ]
    efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline


Secondary Outcome Measures :
  1. Efficacy of NT-KO-003 in relapsing remitting MS patients [ Time Frame: 6 months ]
    efficacy measured as the cumulative number of new lesions (gadolinium enhanced lesions and T2 lesions) in all MRIs

  2. Clinical efficacy of NT-KO-003 in relapsing remitting MS patients [ Time Frame: 6 months ]
    clinical efficacy will be measured as relapse rates and EDSS scale

  3. Safety of NT-KO-003 in patients with relapsing remitting MS patients [ Time Frame: six and a half months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428726


Locations
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Sponsors and Collaborators
Neurotec Pharma
Advancell - Advanced In Vitro Cell Technologies, S.A.
Investigators
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Principal Investigator: Pablo Villoslada, MD PhD Hospital Clinic i Provincial de Barcelona, Spain
More Information
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Responsible Party: Neurotec Pharma
ClinicalTrials.gov Identifier: NCT01428726    
Other Study ID Numbers: NT-KO-003-2010-01
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by Neurotec Pharma:
NT-KO-003
RRMS
efficacy
safety
Phase IIa
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases