E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuropathic Pain From Lumbosacral Radiculopathy |
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E.1.1.1 | Medical condition in easily understood language |
Neuropathic Pain From Lumbosacral Radiculopathy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10050219 |
E.1.2 | Term | Lumbar radiculopathy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 primary objective of the study is to evaluate the long term safety and tolerability of BIIB074 in subjects with neuropathic PLSR. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study are: - To investigate the maintenance of effect during long-term treatment with BIIB074 in subjects with neuropathic PLSR -To evaluate the impact of treatment with BIIB074 on quality of life |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The candidates must meet the following eligibility criteria at enrollment, or at the timepoint specified in the individual eligibility criterion listed: 1.Is able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. 2.Has completed Study 1014802-203 through the Week 14 (Day 99) visit. Subjects who discontinued double-blind study treatment but continued to return for study visits through Week 14 (Day 99) and document their pain scores are eligible unless there are safety concerns |
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E.4 | Principal exclusion criteria |
Exclusion Criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at enrollment, or at the timepoint specified in the individual criterion listed: 1.Had a major protocol deviation regarding inclusion or exclusion criteria for the double-blind Phase 2b study (Study 1014802-203). 2.Had a treatment-related AE or SAE that would pose an increased risk for continued treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b study (Study 1014802-203) due to an AE or SAE. 3.Did not return for study visits through Week 14 (Day 99) after discontinuing treatment in the double-blind phase of the Phase 2b study. 4.Is unable to enroll in the 1014802-204 Study on the 1014802-203 Week 14 (Day 99) visit. 5.Other unspecified reasons that, in the opinion of the Investigator or Convergence Pharmaceuticals, make the subject unsuitable for enrollment.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint that relates to this objective is the incidence of AEs and SAEs during the 12-month open label period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Enrolment at all study visits (w.2, 4, 13, 26, 39, 52 and FU) |
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E.5.2 | Secondary end point(s) |
Efficacy endpoints and timepoints in neuropathic pain: 1. Change from Baseline to Week 52 in the weekly average of the daily neuropathic pain* score on the 11 point Pain Intensity Numerical Rating Scale (PI NRS); subjects will be asked every evening to rate their overall neuropathic pain for the last 24 hour period *Neuropathic pain will be evaluated in the worse affected leg, as identified on Day 1 of Study 1014802-203. 2. 50% neuropathic pain reduction response (yes/no) at Week 52, where a response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52 3. 30% neuropathic pain reduction response (yes/no) at Week 52, where a response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52 4. Changes from Baseline in the weekly average of the daily neuropathic pain score at each visit •Efficacy endpoint in low back pain: 5. Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain; subjects will be asked every evening to rate their overall low back pain for the last 24-hour period. The endpoints that relate to the impact of treatment with BIIB074 on quality of life are as follows: 6. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 52, where a responder is defined as either “much improved” or “very much improved” 7. Change from Baseline to Week 52 on the Oswestry Disability Index 8. Change from Baseline to Week 52 in the weekly average of the daily sleep score; subjects will be asked every morning to rate on the 11-point Sleep Numerical Rating Scale (S-NRS) how leg pain interfered with their sleep quality 9. Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference index 10. Change from Baseline (Week 2) to Week 52 in the BPI-Pain index 11. Change from Baseline to Week 52 on the EuroQoL 5 Dimension 5-Level Questionnaire (EQ 5D-5L) health index 12. Change from Baseline to Week 52 in the Short Form 36 Questionnaire (SF 36)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For timepoints of secondary endpoints please refer to E.5.2. |
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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 | Yes |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 64 |
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 | No |
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 |
Austria |
Belgium |
Bulgaria |
Czech Republic |
Estonia |
Finland |
France |
Georgia |
Italy |
Latvia |
Lithuania |
Romania |
Serbia |
Slovakia |
Spain |
United Kingdom |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 16 |