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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004796-68 | EudraCT Number |
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The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.
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The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen. This is an extension study to 1014802-203.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB074 | Experimental | BIIB074 orally twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB074 | Drug | Participants will receive an initial dose regimen of 350mg orally twice daily (BID), which may be reduced to 200mg based on tolerability for up to 12 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs) | Safety surveillance | Up to 395 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 52 in the weekly average of the daily neuropathic pain score on the Pain Intensity Numerical Rating Scale (PI-NRS) | Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. PI-NRS is an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. | Baseline to Week 52 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Klagenfurt | 9020 | Austria | |||
| Research Site |
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|
| 50% neuropathic pain reduction response | Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52. | At Week 52 |
| 30% neuropathic pain reduction response | Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to week 52. | At Week 52 |
| Change from Baseline at each visit in the weekly average of the daily neuropathic pain score | Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. | Baseline through Week 52 |
| Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain | Participants will be asked every evening to rate their overall low back pain for the last 24-hour period. | Baseline to Week 52 |
| Number of Patient Global Impression of Change (PGIC) responder | PGIC is a 7-point self-report scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | At Week 52 |
| Change from Baseline to Week 52 on the Oswestry Disability Index (ODI) | This is a 10-item questionnaire that evaluates how back (or leg) pain affects the ability to manage in everyday life. Each question is rated on a 5 point scale with higher scores indicating higher level of pain. | Baseline to Week 52 |
| Change from Baseline to Week 52 in the weekly average of the daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS) | Participants will be asked every morning to rate on the 11-point S-NRS how leg pain interfered with their sleep quality where 0=no pain and 10=worst possible pain. | Baseline to Week 52 |
| Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference Index | BPI Interference Index is an 11-point numeric rating scale (0 - no interference to 10 - interferes completely) to assess pain-related interference in 7 areas: general activity, mood, walking ability, normal work, including outside the home and housework, relations with other people, enjoyment of life and sleep. | Baseline to Week 52 |
| Change from Baseline to Week 52 in the BPI - Pain Index | BPI- Pain Index for pain intensity, is used to assess potential pain quality descriptors that may describe participants' pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). | Baseline to Week 52 |
| Change from Baseline to Week 52 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index | The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. | Baseline to Week 52 |
| Change from Baseline to Week 52 in Short Form 36 Questionnaire (SF-36) | SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. | Baseline to Week 52 |
| Leuven |
| 3212 |
| Belgium |
| Research Site | Blagoevgrad | 2700 | Bulgaria |
| Research Site | Rousse | 7003 | Bulgaria |
| Research Site | Sofia | 1000 | Bulgaria |
| Research Site | Sofia | 1431 | Bulgaria |
| Research Site | Sofia | 1784 | Bulgaria |
| Research Site | Sofia | 4001 | Bulgaria |
| Research Site | Veliko Tarnovo | 5000 | Bulgaria |
| Research Site | Beroun | 26601 | Czechia |
| Research Site | Choceň | 56501 | Czechia |
| Research Site | Litoměřice | 41201 | Czechia |
| Research Site | Litomyšl | 57001 | Czechia |
| Research Site | Ostrava | 70200 | Czechia |
| Research Site | Prachatice | 38301 | Czechia |
| Research Site | Prague | 10000 | Czechia |
| Research Site | Prague | 14000 | Czechia |
| Research Site | Prague | 16000 | Czechia |
| Research Site | Prague | 179012 | Czechia |
| Research Site | Zlín | 76001 | Czechia |
| Research Site | Tartu | 51014 | Estonia |
| Research Site | Paris | 75014 | France |
| Research Site | Tbilisi | 0144 | Georgia |
| Research Site | Tbilisi | 0160 | Georgia |
| Research Site | Tbilisi | 0179 | Georgia |
| Research Site | Tbilisi | 0186 | Georgia |
| Research Site | Rome | 00161 | Italy |
| Research Site | Liepāja | LV-3414 | Latvia |
| Research Site | Riga | LV-1002 | Latvia |
| Research Site | Riga | LV-1003 | Latvia |
| Research Site | Bucharest | 010584 | Romania |
| Research Site | Cluj-Napoca | 400437 | Romania |
| Research Site | Craiova | 200642 | Romania |
| Research Site 1 | Belgrade | 11000 | Serbia |
| Research Site 2 | Belgrade | 11000 | Serbia |
| Research Site | Belgrade | 21000 | Serbia |
| Research Site | Banská Bystrica | 974 04 | Slovakia |
| Research Site | Dubnica nad Váhom | 018 41 | Slovakia |
| Research Site | Krompachy | 053 42 | Slovakia |
| Research Site | Pruské | 01852 | Slovakia |
| Research Site | Spišská Nová Ves | 052 01 | Slovakia |
| Research Site | Barcelona | 08907 | Spain |
| Research Site | Granada | 18014 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Madrid | 28690 | Spain |
| Research Site | Madrid | 28938 | Spain |
| Research Site | Edinburgh | EH4 2XU | United Kingdom |
| Research Site | Liverpool | L9 7LI | United Kingdom |
| Research Site | London | NW3 2QG | United Kingdom |
| Research Site | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| C000592131 | vixotrigine |
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