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

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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

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE September 5, 2011
Last Update Posted Date March 18, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01428726 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2012)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
  • Efficacy of NT-KO-003 in relapsing remitting MS patients [ Time Frame: 6 months ]
    efficacy measured as the cumulative number of new lesions (gadolinium enchanced lesions and T2 lesions) in all MRIs
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase IIa Study of NT-KO-003 for Multiple Sclerosis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Remitting Multiple Sclerosis
Intervention  ICMJE Drug: NT-KO-003
NT-KO-003 is a coated tablet, administered once a day
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: NT-KO-003
  • Experimental: NT-KO-003 low dose
    Intervention: Drug: NT-KO-003
  • Experimental: NT-KO-003 high dose
    Intervention: Drug: NT-KO-003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 15, 2012)
99
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2011)
105
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01428726
Other Study ID Numbers  ICMJE NT-KO-003-2010-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neurotec Pharma
Study Sponsor  ICMJE Neurotec Pharma
Collaborators  ICMJE Advancell - Advanced In Vitro Cell Technologies, S.A.
Investigators  ICMJE
Principal Investigator: Pablo Villoslada, MD PhD Hospital Clinic i Provincial de Barcelona, Spain
PRS Account Neurotec Pharma
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP