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The primary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on paroxysmal pain in participants with Primary Inherited Erythromelalgia (EM). The secondary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on varying additional aspects of pain in participants with EM; and to investigate the safety and tolerability of repeat oral dosing of BIIB074 in participants with EM.
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Group 1 | Experimental | After two week run-in, BIIB074 three times a day (TID) followed by placebo (TID) after two week washout period |
|
| Randomized Group 2 | Experimental | After two week run-in, Placebo three times a day (TID) followed by BIIB074 (TID) after two week washout period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB074 | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weekly average severity of paroxysms | 11-point Pain Intensity Numerical Rating Scale (PI-NRS) is used to assess EM paroxysmal pain. PI-NRS is an 11-point pain intensity numerical rating scale, where 0=no pain and 10=worst possible pain. Weekly average is defined as the total of severity scores during a week divided by the total number of paroxysms during that week. | Day 1 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly maximum severity of paroxysms | The weekly maximum severity is the maximum paroxysm severity recorded by a participant in a given week. | Day 1 to Week 12 |
| Weekly average and maximum number of paroxysms |
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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 | Birmingham | Alabama | 35242 | United States | ||
| Research SIte |
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| ID | Term |
|---|---|
| C000592131 | vixotrigine |
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| Placebo | Drug | Matched placebo |
|
| Day 1 to Week 12 |
| Weekly average and weekly maximum duration of paroxysms | Day 1 to Week 12 |
| Weekly average and weekly maximum of daily background pain | Each participant provides a daily background pain score via a diary that records background daily pain intensity using a numerical rating scale from 0-10 with higher scores indicating worse pain. | Day 1 to Week 12 |
| Patient Global Impression of Change (PGIC) score | 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." | Day 1 to Week 12 |
| Weekly average and weekly maximum number of pain-mitigating activities | Participant diary is used to record pain mitigating cooling activities that include but are not limited to use of cold water or fan. | Day 1 to Week 12 |
| Weekly average and weekly maximum duration of pain-mitigating activities | Participant diary is used to record pain mitigating activities that include but are not limited to use of cooling, and breathing/relaxation and mental imagery techniques. | Day 1 to Week 12 |
| Use of rescue medication | Day 1 to Week 13 |
| Weekly average and weekly maximum of the daily sleep interference scale | Daily Sleep Interference Scale (DSIS) describes how much EM pain interfered with the participant's sleep with 0 indicating "pain did not interfere with sleep" and 10 indicating "pain completely interfered with sleep". | Day 1 to Week 12 |
| Weekly average and weekly maximum number of awakenings at night due to EM pain | Day 1 to Week 12 |
| Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs) | Up to Week 13 |
| Number of participants with clinically significant vital sign abnormalities | Up to Week 13 |
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities | Up to Week 13 |
| Number of participants with clinically significant laboratory safety test abnormalities | Up to Week 13 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) assessment | C-SSRS is a suicidal ideation rating used to evaluate suicidality. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." | Up to Week 13 |
| New London |
| Connecticut |
| 06320 |
| United States |
| Research Site | Philadelphia | Pennsylvania | 19152 | United States |
| Research Site | Plano | Texas | 75075 | United States |
| Research Site | Morgantown | West Virginia | 26505 | United States |