- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070132
802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia (SURGE-1)
May 4, 2023 updated by: Biogen
A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN).
Secondary objectives of this study are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetics (PK) of BIIB074.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- A diagnosis of trigeminal neuralgia (TN) for at least 3 months based on International Headache Society (IHS) diagnostic criteria.
- Participant must have failed at least 1 prior standard of care pharmacologic treatment for TN (defined as an inadequate response or intolerance to treatment), as determined by the Investigator based on medical history.
- Age ≥18 years at the time of informed consent.
- Allowed concomitant medications must have been stable for at least 4 weeks prior to Day 1 of the dose-optimization period. The maximum dosage of carbamazepine allowed on Day 1 is 400 mg/day (or 600 mg/day for oxcarbazepine).
- Participants must have recorded their pain score in their eDiary on at least 5 days during the run-in period (Days -7 to -1).
Key Exclusion Criteria:
- History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
- Positive history of human immunodeficiency virus (HIV) or a positive HIV test at Screening.
- Participants with facial pain other than TN.
- Personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury.
- Known hypersensitivity to BIIB074 or components of the BIIB074 formulation or matching placebo.
- Positive pregnancy test result at Screening (women of childbearing potential only)
- Has donated blood or blood products within a 30-day period prior to Screening.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIIB074
Optimized oral dose three times daily (TID)
|
Administered as specified in the treatment arm
Other Names:
|
Experimental: Placebo
Administered orally TID
|
Matched placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Classified as Responders at Week 12 of the Double-Blind Period
Time Frame: Week 12
|
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
Time Frame: Baseline up to Week 52
|
An AE is any untoward medical occurrence in a participant or clinical investigation participant 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 participant 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Plasma Concentration- Time Curve at Steady State (AUC,ss)
Time Frame: Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)
|
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)
|
Percentage of Participants with >=30% Reduction From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period
Time Frame: Week 1 through Week 52
|
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
Time Frame: Baseline, Week 1 through Week 52
|
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
Time Frame: Week 1 through Week 52
|
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
Time Frame: Baseline, Week 1 through Week 52
|
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 Classified as Responders Achieving Patient Global Impression of Change (PGIC) Response at Week 12 of the Double- Blind Period
Time Frame: Week 12
|
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-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."
|
Week 12
|
Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Number of Paroxysms at Week 12
Time Frame: 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
Time Frame: 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 Double Blind Period
Time Frame: Up to Week 14 of Double blind period
|
An AE is any untoward medical occurrence in a participant or clinical investigation participant 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 participant 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
|
Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
Time Frame: Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)
|
Cmax,ss= Maximum Observed Plasma Concentration at Steady State
|
Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)
|
Change From Baseline In Mean Worst Pain Score During the Long Term Extension (LTE) Period
Time Frame: Baseline, Week 1 through Week 52
|
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 a PGIC Response of "Much Improved or "Very Much Improved" by Visit During the Long Term Extension (LTE) Period
Time Frame: Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52
|
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 having response "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 Facial Pain Scale-Revised (PENN-FPS-R) Score by Visit During the Long Term Extension (LTE) Period
Time Frame: Baseline, Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52
|
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 EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Score by Visit During the Long Term Extension (LTE) Period
Time Frame: Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52
|
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 Work Productivity and Activity Impairment (WPAI) Neuropathic Pain (V2.0) Score by Visit During the Long Term Extension (LTE) Period
Time Frame: Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 19, 2023
Primary Completion (Anticipated)
October 14, 2025
Study Completion (Anticipated)
August 21, 2026
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
February 28, 2017
First Posted (Actual)
March 3, 2017
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 802NP301
- 2016-001449-16 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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