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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NT-KO-003
Sponsored by
Neurotec Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring NT-KO-003, RRMS, efficacy, safety, Phase IIa

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin
  • Klinik und Poliklinik für Neurologie
  • Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
  • Hospital Germans Trias i Pujol
  • Hospital Clinic i Provincial
  • Hospital del Mar
  • Hospital Vall d'Hebrón
  • Hospital Universitari Josep Trueta
  • Hospital Clínico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario La Princesa
  • Hospital Universitario Puerta del Hierro
  • Hospital Regional Universitario Carlos Haya
  • Complexo Hospitalario Universitario de Santiago
  • Hospital Universitario La Fe
  • Hospital Xeral Vigo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

NT-KO-003 low dose

NT-KO-003 high dose

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Clinical efficacy of NT-KO-003 in relapsing remitting MS patients
clinical efficacy will be measured as relapse rates and EDSS scale
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

Full Information

First Posted
August 31, 2011
Last Updated
March 15, 2014
Sponsor
Neurotec Pharma
Collaborators
Advancell - Advanced In Vitro Cell Technologies, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01428726
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurotec Pharma
Collaborators
Advancell - Advanced In Vitro Cell Technologies, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
NT-KO-003, RRMS, efficacy, safety, Phase IIa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
NT-KO-003 low dose
Arm Type
Experimental
Arm Title
NT-KO-003 high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NT-KO-003
Intervention Description
NT-KO-003 is a coated tablet, administered once a day
Primary Outcome Measure Information:
Title
Efficacy of NT-KO-003 in patients with relapsing remitting MS patients
Description
efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy of NT-KO-003 in relapsing remitting MS patients
Description
efficacy measured as the cumulative number of new lesions (gadolinium enhanced lesions and T2 lesions) in all MRIs
Time Frame
6 months
Title
Clinical efficacy of NT-KO-003 in relapsing remitting MS patients
Description
clinical efficacy will be measured as relapse rates and EDSS scale
Time Frame
6 months
Title
Safety of NT-KO-003 in patients with relapsing remitting MS patients
Description
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
Time Frame
six and a half months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Villoslada, MD PhD
Organizational Affiliation
Hospital Clinic i Provincial de Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin
City
Berlin
Country
Germany
Facility Name
Klinik und Poliklinik für Neurologie
City
Münster
Country
Germany
Facility Name
Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
City
Wiesbaden
Country
Germany
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Josep Trueta
City
Girona
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta del Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya
City
Málaga
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Xeral Vigo
City
Vigo
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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