Clinical Trial: Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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). 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.

Detailed Summary:
Sponsor: Biogen

Current Primary Outcome: Number of participants with a response in Average Daily Pain (ADP) [ Time Frame: Up to Week 52 ]

Data for all assessments will be recorded daily in the eDiary.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time from randomization to loss of therapeutic response (LOTR) [ Time Frame: Up to Week 52 ]
  • Change from baseline in weekly mean ADP [ Time Frame: Up to Week 52 ]
  • Number of participants with a response in number of paroxysms [ Time Frame: Up to Week 52 ]
  • Number of participants with a Patient Global Impression of Change (PGIC) response [ Time Frame: 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."
  • Change from baseline in the Penn Facial Pain Scale-Revised (PENN-FPS-R) score [ Time Frame: Up to Week 52 ]
    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.
  • Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 52 ]
  • Number of participants with clinically significant vital sign abnormalities [ Time Frame: Up to Week 52 ]
  • Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: Up to Week 52 ]
  • Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: Up to Week 52 ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS ) [ Time Frame: UP to Week 52 ]
  • BIIB074 concentrations in plasma [ Time Frame: Up to Week 52 ]
  • PK of BIIB074 Oral clearance (CL/F) [ Time Frame: Up to Week 52 ]
  • PK of BIIB074 Central volume of distribution (V/F) [ Time Frame: Up to Week 52 ]
  • PK of BIIB074 absorption rate constant (Ka) [ Time Frame: Up to Week 52 ]
  • PK of BIIB074 Area under the curve (AUC) [ Time Frame: Up to Week 52 ]
  • PK of BIIB074 Cmax (maximum plasma concentration) [ Time Frame: Up to Week 52 ]


Original Secondary Outcome: Same as current

Information By: Biogen

Dates:
Date Received: February 28, 2017
Date Started: July 2017
Date Completion: June 2020
Last Updated: February 28, 2017
Last Verified: February 2017