None listed
Conditions
Interventions
Sponsors
Newron Pharmaceuticals SpA
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from Baseline (Study NW-1029/01-08) in the daily pain score and effects of pain on sleep and activity (11-point Likert scales), as assessed by the patient ? change from Baseline (Study NW-1029/01-08) in the patient?s perception of burning pain and shooting pain (11-point Likert scales), as assessed by the investigator ? change from Baseline (Study NW-1029/01-08) in the Visual Analogue Scale (VAS; 100-mm) ? change in the Neuropathic Pain Symptom Inventory (NPSI) compared with Baseline (Study NW- 1029/01-08). Safety Assessments: Adverse events (AE) ? Vital signs (systolic/diastolic blood pressure, pulse, body weight, body temperature) ? Laboratory evaluations (blood chemistry, hematology, urinalysis) ? Electrocardiogram (ECG) ? 12-lead, standard ? Physical examination ? Neurological examination ? Ophthalmological examinationsTimepoint: change from Baseline (Study NW-1029/01-08) in the daily pain score and effects of pain on sleep and activity (11-point Likert scales), as assessed by the patient ? change from Baseline (Study NW-1029/01-08) in the patient?s perception of burning pain and shooting pain (11-point Likert scales), as assessed by the investigator ? change from Baseline (Study NW-1029/01-08) in the Visual Analogue Scale (VAS; 100-mm) ? change in the Neuropathic Pain Symptom Inventory (NPSI) compared with Baseline (Study NW- 1029/01-08). Safety Assessments: Adverse events (AE) ? Vital signs (systolic/diastolic blood pressure, pulse, body weight, body temperature) ? Laboratory evaluations (blood chemistry, hematology, urinalysis) ? Electrocardiogram (ECG) ? 12-lead, standard ? Physical examination ? Neurological examination ? Ophthalmological examinations | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Rajat Hazra
CliniRx Research Pvt Ltd
Outcome results
None listed