Clinical trial to evaluate the long-term safety and efficacy of ralfinamide in patients with chronic neuropathic low back pai
- Registration Number
- CTRI/2009/091/000177
- Lead Sponsor
- ewron Pharmaceuticals SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method