A MULTICENTER, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, EXTENSION STUDY TO ASSESS LONG-TERM SAFETY AND EFFICACY OF TWO FIXED DOSES OF RALFINAMIDE (160 OR 320 MG/DAY) IN PATIENTS WITH CHRONIC NEUROPATHIC LOW BACK PAIN - ND

• Conditions: europathic pain; MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

• Registration Number: EUCTR2008-006159-39-IT
• Lead Sponsor: EWRON PHARMACEUTICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patient has been informed about the study and has given her/his written informed consent. 2. Patient completed the treatment period of study NW-1029/01-08, or, if the patient discontinued prematurely, he/she returned for at least 2 of the scheduled efficacy evaluations at Weeks 2, 4, 6, and 9 and completed the final efficacy evaluation at Week 12 as part of the Retrieved Dropout RDO) population. 3. Patient was compliant with taking study medication in study NW-1029/01-08. 4. Patient understands the investigational nature of the extension study and is willing and able to comply with the study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient is unwilling or unable to give written informed consent. 2. Patient has a serious AE (SAE) or clinically significant medical condition ongoing from study NW-1029/01-08 that would put them at risk for continuing treatment, or has deteriorated significantly during the initial treatment period. 3. Patient discontinued Study NW-1029/01-08 prematurely for any reason, and did not return for at least 2 of the scheduled efficacy evaluations at Weeks 2, 4, 6, and 9 and complete the final efficacy evaluation at Week 12 as part of the RDO population.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of this study are to evaluate the long-term safety and efficacy of two fixed doses of orally administered ralfinamide (160 or 320 mg/day), compared to placebo, in patients with chronic neuropathic low back pain.;Secondary Objective: N/A;Primary end point(s): In the analysis of the efficacy measurements (Likert scales, VAS, and NPSI), the changes from baseline (Study NW-1029/01-08) will be analyzed. Treatment differences at the Final Visit between the active treatment groups and the placebo group, as well as 95% confidence intervals of the treatment differences, including p-values, based on the model, will be presented.