802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia

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."

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.

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.

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.

AUC,ss= Area under the plasma concentration versus time curve (AUC) at steady state.

Cmax,ss= Maximum Observed Plasma Concentration of BIIB074 at Steady State

Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain.

Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain.

Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain.

Paroxysms are trigeminal neuralgia pain attacks. They are short, severe, and sharp, shooting, stabbing, or shock-like.

Paroxysms are trigeminal neuralgia pain attacks. They are short, severe, and sharp, shooting, stabbing, or shock-like.

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.

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.

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.

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.