E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic neuropathic low back pain |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 one 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. In the case of patients who discontinue treatment and become RDOs after Visit 7 (Week 9), only the final visit would be required.
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.
|
|
E.4 | Principal 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 one 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.
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is defined as the LPLV. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |