A Phase IIa Study of NT-KO-003 for Multiple Sclerosis
This study is currently recruiting participants.
Verified March 2013 by Neurotec Pharma
Sponsor:
Neurotec Pharma
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 26, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428726
Contacts
| Contact: Marco Pugliese | +34935189908 | marcopugliese@neurotec-pharma.com |
Locations
| Germany | |
| Charité Universitätsmedizin | Recruiting |
| Berlin, Germany | |
| Principal Investigator: Friedemann Paul, MD | |
| Klinik und Poliklinik für Neurologie | Recruiting |
| Münster, Germany | |
| Principal Investigator: Sven Meuth, MD | |
| Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH | Recruiting |
| Wiesbaden, Germany | |
| Principal Investigator: Eckhart Lensch, MD | |
| Spain | |
| Hospital Germans Trias i Pujol | Recruiting |
| Badalona, Spain | |
| Principal Investigator: Cristina Ramo, MD | |
| Hospital Vall d'Hebrón | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Xavier Montalbán, MD | |
| Hospital Clinic i Provincial | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Albert Saiz, MD | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Enrique Martinez, MD | |
| Hospital Universitari Josep Trueta | Recruiting |
| Girona, Spain | |
| Principal Investigator: Lluís Ramió, MD | |
| Hospital Universitario La Princesa | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Virginia Meca, MD | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Cecilia Oreja Guevara, MD | |
| Hospital Clínico San Carlos | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Rafael Arroyo, MD | |
| Hospital Universitario Puerta del Hierro | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Antonio García Merino, MD | |
| Hospital Universitario 12 de Octubre | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Julian Benito Leon, MD | |
| Hospital Regional Universitario Carlos Haya | Recruiting |
| Málaga, Spain | |
| Principal Investigator: Oscar Fernández, MD | |
| Complexo Hospitalario Universitario de Santiago | Recruiting |
| Santiago de Compostela, Spain | |
| Principal Investigator: José M Prieto, MD | |
| Hospital Universitario La Fe | Recruiting |
| Valencia, Spain | |
| Principal Investigator: Bonaventura Casanova, MD | |
| Hospital Xeral Vigo | Recruiting |
| Vigo, Spain | |
| Principal Investigator: Delicias Muñoz, MD | |
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 26, 2013 |
| 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 May 21, 2013