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A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS

NCT03283397 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2024-08-13

No results posted yet for this study

Summary

Multiple sclerosis is a chronic autoimmune, inflammatory neurological disease of the central nervous system. It is the most common disabling neurologic disease of young people. This study is planned for the evaluation of efficacy, safety and tolerability of neuropeptide combination of metenkefalin and tridecactide (EK-12) as compared to INF beta-1a (REBIF®) in patients with RRMS. The primary objective of this study is to prove the superiority of efficacy of neuropeptide combination of metenkefalin and tridecactide (EK-12) compared to INF beta-1a (REBIF®) in patients with RRMS on the basis of annualized protocol defined relapse rate by 144 weeks.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

EK-12

10 mg metenkefalin acetate + 2 mg tridecactide acetate in 2 mL 0.9 % NaCl solution.

DRUG

INF beta-1a

Active substance is INF beta-1a, 44 mcg in 0.5 mL solution

Sponsors & Collaborators

  • MonitorCRO

    collaborator INDUSTRY

  • Bosnalijek D.D

    lead INDUSTRY

Principal Investigators

  • Husnu Efendi, Prof · Kocaeli University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283397 on ClinicalTrials.gov