A Phase IIa Study of NT-KO-003 for Multiple Sclerosis
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Interventions
- Drug: NT-KO-003
- Registration Number
- NCT01428726
- Lead Sponsor
- Neurotec Pharma
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo NT-KO-003 - NT-KO-003 low dose NT-KO-003 - NT-KO-003 high dose NT-KO-003 -
- Primary Outcome Measures
Name Time Method Efficacy of NT-KO-003 in patients with relapsing remitting MS patients 6 months efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline
- Secondary Outcome Measures
Name Time Method Efficacy of NT-KO-003 in relapsing remitting MS patients 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 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 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
Trial Locations
- Locations (17)
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Charité Universitätsmedizin
🇩🇪Berlin, Germany
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Klinik und Poliklinik für Neurologie
🇩🇪Münster, Germany
Hospital Universitari Josep Trueta
🇪🇸Girona, Spain
Hospital Xeral Vigo
🇪🇸Vigo, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Málaga, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Puerta del Hierro
🇪🇸Madrid, Spain
Complexo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
🇩🇪Wiesbaden, Germany
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain