Clinical trial NCT01428726: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: NT-KO-003
RRMS
efficacy
safety
Phase IIa
Lead sponsor: Neurotec Pharma
Sponsor class: INDUSTRY
Collaborators: name: Advancell - Advanced In Vitro Cell Technologies, S.A.
First posted: 2011-09-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Efficacy of NT-KO-003 in patients with relapsing remitting MS patients
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of NT-KO-003 in relapsing remitting MS patients
timeFrame: 6 months
measure: Clinical efficacy of NT-KO-003 in relapsing remitting MS patients
timeFrame: 6 months
measure: Safety of NT-KO-003 in patients with relapsing remitting MS patients
timeFrame: six and a half months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin
city: Münster
country: Germany
facility: Klinik und Poliklinik für Neurologie
city: Wiesbaden
country: Germany
facility: Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Girona
country: Spain
facility: Hospital Universitari Josep Trueta
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Puerta del Hierro
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Vigo
country: Spain
facility: Hospital Xeral Vigo
Study officials:
affiliation: Hospital Clinic i Provincial de Barcelona, Spain
name: Pablo Villoslada, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: