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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002473-35 | EudraCT Number |
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Sponsor Decision
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The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN).
The secondary objectives are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetic(s) (PK) of BIIB074.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB074 | Experimental | Administered orally three times daily (TID) |
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| Placebo | Placebo Comparator | Placebo matching BIIB074 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB074 | Drug | Administered as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Classified as Responders at Week 12 of the Double- Blind Period | A participant who meets all of the following criteria will be classified as a responder: (1) Has a reduction of >=30% in mean pain score compared with baseline; (2) Has not discontinued randomized treatment before the end of Week 12 of the double-blind period; (3) Has not taken prohibited pain medication before the end of Week 12 of the double-blind period. | Week 12 |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Long Term Extension (LTE) Period | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. | Baseline up to Week 52 of the LTE |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Classified as Responders Achieving Patient Global Impression of Change (PGIC) Response at Week 12 of the Double-Blind Period | A participant who meets all of the following criteria will be classified as a responder: (1) Achieving Patient Global Impression of Change (PGIC) response of "Much Improved" or "Very Much Improved" at Week 12 of the double-blind period; (2) has not discontinued randomized study treatment before the end of Week 12 of the double-blind period; (3) has not taken prohibited pain medication before the end of Week 12 of the double-blind period. PGIC is a 7-item 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." |
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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 |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C000592131 | vixotrigine |
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| Placebo |
| Drug |
Administered as specified in the treatment arm. |
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| Week 12 |
| Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Number of Paroxysms at Week 12 | A participant who meets all of the following criteria will be classified as a responder: (1) Achieving >=50 percent reduction from baseline mean number of paroxysms at Week 12; (2) has not discontinued randomized study treatment before the end of Week 12 of the double-blind period; (3) has not taken prohibited pain medication before the end of Week 12 of the double-blind period. A paroxysm is a trigeminal neuralgia pain attack. | Week 12 |
| Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Pain Score at Week 12 | A participant who meets all of the following criteria will be classified as a responder: (1) Achieving >=50 percent reduction from baseline mean pain score at Week 12; (2) has not discontinued randomized study treatment before the end of Week 12 of the double-blind period; (3) has not taken prohibited pain medication before the end of Week 12 of the double-blind period. Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain. | Week 12 |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double Blind Period | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. | Up to Week 14 of Double blind period |
| Area Under the Plasma Concentration- Time Curve at Steady State (AUC,ss) | AUC,ss= Area under the plasma concentration versus time curve (AUC) at steady state. | Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred) |
| Maximum Observed Plasma Concentration at Steady State (Cmax,ss) | Cmax,ss= Maximum Observed Plasma Concentration of BIIB074 at Steady State | Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred) |
| Percentage of Participants with >=30% Reduction From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period | Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain. | Week 1 through Week 52 |
| Change From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period | Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain. | Baseline, Week 1 through Week 52 |
| Change From Baseline in Mean Worst Pain Score During the Long Term Extension (LTE) Period | Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain. | Baseline, Week 1 through Week 52 |
| Percentage of Participants with >=50% Reduction From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period | Paroxysms are trigeminal neuralgia pain attacks. They are short, severe, and sharp, shooting, stabbing, or shock-like. | Week 1 through Week 52 |
| Change From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period | Paroxysms are trigeminal neuralgia pain attacks. They are short, severe, and sharp, shooting, stabbing, or shock-like. | Baseline, Week 1 through Week 52 |
| Percentage of Participants With a PGIC Response of "Much Improved or "Very Much Improved" by Visit During the Long Term Extension (LTE) Period | 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." Participants with "Much Improved or "Very Much Improved" will be reported. | Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52 |
| Change From Baseline in the PENN-FPS-R Score by Visit During the Long Term Extension (LTE) Period | The Penn-FPS-R is a new 12-item Health-Related Quality of Life outcome measure with content validity that can be used to assess and monitor the impact of Trigeminal Neuralgia and facial pain treatment interventions in both clinical practice and research. This scale uses the 0-10 numeric rating scale (NRS) to quantify the pain impact different activities and quality of life items, where 0 indicates no interference and 10 indicates complete interference. The sum of the rated NRS score will be calculated. | Baseline, Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52 |
| Change From Baseline in the EQ-5D-5L Score by Visit During the Long Term Extension (LTE) Period | EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has no problems, slight problems, moderate problems, severe problems, and extreme problems. A negative change from Baseline indicates improvement. | Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52 |
| Change From Baseline in the WPAI Neuropathic Pain (V2.0) Score by Visit During the Long Term Extension (LTE) Period | The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteeism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52 |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |