802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia (NCT03637387) | Clinical Trial Compass
WithdrawnPhase 3
802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
Stopped: Sponsor Decision
0Started 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \[methamphetamines and 3,4-methylenedioxymethamphetamine\], phencyclidine, barbiturates, benzodiazepines, cocaine, opioi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Classified as Responders at Week 12 of the Double- Blind Period
Timeframe: Week 12
2
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Long Term Extension (LTE) Period