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

NCT03637387 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: 802NP3022016-002473-35
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trigeminal Neuralgia

Keywords

TGN; TN

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (15)

• Percentage of Participants Classified as Responders Achieving Patient Global Impression of Change (PGIC) Response at Week 12 of the Double-Blind Period

  Week 12

• Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Number of Paroxysms at Week 12

  Week 12

• Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Pain Score at Week 12

  Week 12

• Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double Blind Period

  Up to Week 14 of Double blind period

• Area Under the Plasma Concentration- Time Curve at Steady State (AUC,ss)

  Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)

Study Arms (2)

BIIB074

EXPERIMENTAL

Administered orally three times daily (TID)

Drug: BIIB074

Placebo

PLACEBO COMPARATOR

Placebo matching BIIB074

Drug: Placebo

Interventions

BIIB074 DRUG

Administered as specified in the treatment arm

BIIB074

Placebo DRUG

Administered as specified in the treatment arm.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 \[methamphetamines and 3,4-methylenedioxymethamphetamine\], phencyclidine, 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.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

vixotrigine

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: March 1, 2023
• Primary Completion: August 18, 2025
• Study Completion (Estimated): September 29, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share