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

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ClinicalTrials.gov Identifier: NCT03637387
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE August 20, 2018
Last Update Posted Date December 14, 2018
Estimated Study Start Date  ICMJE July 31, 2020
Estimated Primary Completion Date August 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • 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.
  • 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 104 of the LTE ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03637387 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • 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 selfreport 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."
  • 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.11-point Pain Intensity Numerical Rating Scale (PINRS) is used to assess TM paroxysmal pain. PINRS 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.
  • 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.
  • Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double Blind Period [ Time Frame: Up to Week 14 of 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.
  • 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.
  • 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 of BIIB074 at Steady State
  • 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 104 ]
    Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain.
  • Change From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period [ Time Frame: Baseline, Week 1 through Week 104 ]
    Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain.
  • Change From Baseline in Mean Worst Pain Score During the Long Term Extension (LTE) Period [ Time Frame: Baseline, Week 1 through Week 104 ]
    Pain score is a 11-point numerical rating scale where 0 = no pain; 10 = maximum pain imaginable. Higher scores representing more pain.
  • 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 104 ]
    11-point Pain Intensity Numerical Rating Scale (PI-NRS) is used to assess TM 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.
  • Change From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period [ Time Frame: Baseline, Week 1 through Week 104 ]
    11-point Pain Intensity Numerical Rating Scale (PI-NRS) is used to assess TM 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.
  • 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 104 ]
    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.
  • Change From Baseline in the 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 104 ]
    A self-report measure of pain intensity adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric; "0" equals "No pain" and "10" equals "Very much pain.
  • Change From Baseline in the 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 104 ]
    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" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
  • Change From Baseline in the 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 104 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
Official Title  ICMJE A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Trigeminal Neuralgia
Intervention  ICMJE
  • Drug: BIIB074
    Administered as specified in the treatment arm
  • Drug: Placebo
    Matched placebo
Study Arms  ICMJE
  • Experimental: BIIB074 Dose 1
    Administered orally three times daily (TID)
    Interventions:
    • Drug: BIIB074
    • Drug: Placebo
  • Experimental: BIIB074 Dose 2
    Administered orally TID
    Interventions:
    • Drug: BIIB074
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2018)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 7, 2023
Estimated Primary Completion Date August 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Participants must have recorded their pain score in their eDiary on at least 5 days during the run-in period (Days -7 to -1).
  • 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).

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.
  • Positive drug screen for drugs of abuse at Screening (amphetamine, barbiturates, benzodiazepines, cocaine, opioids) except if explained by use of allowed prescription medicines. Prospective subjects with a positive screen for tetrahydrocannabinol must agree to discontinue use upon study enrollment and for the duration of the study.
  • Known hypersensitivity to BIIB074 or components of the BIIB074 formulation or matching placebo.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03637387
Other Study ID Numbers  ICMJE 802NP302
2016-002473-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP