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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 99
- Locations
- 17
- Primary Endpoint
- Efficacy of NT-KO-003 in patients with relapsing remitting MS patients
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
NT-KO-003 low dose
Intervention: NT-KO-003 (Drug)
NT-KO-003 high dose
Intervention: NT-KO-003 (Drug)
Placebo
Intervention: NT-KO-003 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Efficacy of NT-KO-003 in relapsing remitting MS patients(6 months)
- Clinical efficacy of NT-KO-003 in relapsing remitting MS patients(6 months)
- Safety of NT-KO-003 in patients with relapsing remitting MS patients(six and a half months)