Neuropathic Pain From Lumbosacral Radiculopathy Clinical Trial
— RELAY-1 ExtendOfficial title:
An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
| Verified date | February 2019 |
| Source | Biogen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 302 |
| Est. completion date | February 7, 2019 |
| Est. primary completion date | February 7, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Key Inclusion Criteria: - Has completed Study 1014802-203 for its complete duration. Key Exclusion Criteria: - Has met an exclusion criterion for the preceding double-blind Phase 2b study (Study 1014802-203). - Had a protocol deviation regarding inclusion or exclusion criteria for the double-blind Phase 2b study (Study 1014802-203). - 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. - Did not return for all study visits after discontinuing treatment in the double-blind phase of the Phase 2b study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Klagenfurt | |
| Belgium | Research Site | Leuven | |
| Bulgaria | Research Site | Blagoevgrad | |
| Bulgaria | Research Site | Ruse | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Veliko Tarnovo | |
| Czechia | Research Site | Beroun | |
| Czechia | Research Site | Chocen | |
| Czechia | Research Site | Litomerice | |
| Czechia | Research Site | Litomysl | |
| Czechia | Research Site | Ostrava | |
| Czechia | Research Site | Prachatice | |
| Czechia | Research Site | Prague | |
| Czechia | Research Site | Prague | |
| Czechia | Research Site | Prague | |
| Czechia | Research Site | Prague | |
| Czechia | Research Site | Zlin | |
| Estonia | Research Site | Tartu | |
| France | Research Site | Paris | |
| Georgia | Research Site | Tbilisi | |
| Georgia | Research Site | Tbilisi | |
| Georgia | Research Site | Tbilisi | |
| Georgia | Research Site | Tbilisi | |
| Italy | Research Site | Rome | |
| Latvia | Research Site | Liepaja | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Riga | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Cluj-Napoca | |
| Romania | Research Site | Craiova | |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site 1 | Belgrade | |
| Serbia | Research Site 2 | Belgrade | |
| Slovakia | Research Site | Banska Bystrica | |
| Slovakia | Research Site | Dubnica nad Vahom | |
| Slovakia | Research Site | Krompachy | |
| Slovakia | Research Site | Pruske | |
| Slovakia | Research Site | Spisska Nova Ves | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Granada | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| United Kingdom | Research Site | Edinburgh | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London |
| Lead Sponsor | Collaborator |
|---|---|
| Biogen |
Austria, Belgium, Bulgaria, Czechia, Estonia, France, Georgia, Italy, Latvia, Romania, Serbia, Slovakia, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs) | Safety surveillance | Up to 395 Days | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |