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Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back Pain

NCT01019824 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2017-09-15

No results posted yet for this study

Summary

The aim of the study is to determine if an experimental drug, ralfinamide, relieves your neuropathic low back pain, and if it demonstrates superiority to placebo, a "dummy" or sugar pill that contains no active medication. Ralfinamide, given as either 160 mg/day or 320 mg/day, taken in a divided dose twice-a-day, will be compared with placebo. If you are randomly (by chance) selected to receive placebo, you will receive this medication throughout the treatment period of the study. Data from this study will provide essential information for choosing the doses of ralfinamide to be used in the treatment of this type of pain and potentially other types of pain.

Conditions

Interventions

DRUG

Ralfinamide

Ralfinamide Oral Tablets, 160 or 320 mg per day

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • CliniRx

    collaborator UNKNOWN

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

  • Stefano Rossetti, MD · Newron Pharmaceuticals SPA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-20
Primary Completion
2010-05-11
Completion
2011-08-09

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01019824 on ClinicalTrials.gov