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Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

NCT01464905 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2013-09-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

BIOLOGICAL

NU100

0.25 mg SQ, every other day for 12 months

BIOLOGICAL

Placebo

1 mL SQ, every other day for 4 months

BIOLOGICAL

rhIFN beta-1b

0.25 mg SQ, every other day for 12 months

Sponsors & Collaborators

  • Nuron Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Tracy L Goeken, M.D. · Nuron Biotech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Belarus
  • Bulgaria
  • Croatia
  • Georgia
  • Hungary
  • Italy
  • Lebanon
  • Poland
  • Russia
  • Serbia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT01464905 on ClinicalTrials.gov