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

• ClinicalTrials.gov Identifier: NCT01428726
• Recruitment Status: Completed
• First Posted: September 5, 2011
• Last Update Posted: March 18, 2014
• Sponsor: Neurotec Pharma
• Collaborator: Advancell - Advanced In Vitro Cell Technologies, S.A.
• Information provided by (Responsible Party): Neurotec Pharma

Tracking Information

• First Submitted Date: August 31, 2011
• First Posted Date: September 5, 2011
• Last Update Posted Date: March 18, 2014
• Study Start Date: June 2011
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: A Phase IIa Study of NT-KO-003 for Multiple Sclerosis
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Relapsing Remitting Multiple Sclerosis

Intervention

Drug: NT-KO-003

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 15, 2012): 99
• Original Estimated Enrollment (submitted: September 2, 2011): 105
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Spain

Administrative Information

• NCT Number: NCT01428726
• Other Study ID Numbers: NT-KO-003-2010-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Neurotec Pharma
• Original Responsible Party: Advancell - Advanced In Vitro Cell Technologies, S.A.
• Current Study Sponsor: Neurotec Pharma
• Original Study Sponsor: Advancell - Advanced In Vitro Cell Technologies, S.A.
• Collaborators: Advancell - Advanced In Vitro Cell Technologies, S.A.

Investigators

• Principal Investigator: Pablo Villoslada, MD PhD; Hospital Clinic i Provincial de Barcelona, Spain

• PRS Account: Neurotec Pharma
• Verification Date: March 2014