Approval Probability
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Also known as Trigriluzole, BHV-4157, FC-4157, C15H16F3N5O4S.HCl.H2O
troriluzole · 8 trials · 21 indications
Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.
Improvement is measured by a lower total score
The f-SARA was a 4-item performance based scale: 1-gait, 2-stance, 3-sitting, 4-speech disturbance (0:normal (no impairment), 1: mildly impaired function, but no assistance required, 2: moderately impaired function, but needs assistance for certain parts of task, 3: severely impaired function to degree that assistance is needed for all parts of the task, 4: unable to perform function). Total score was derived as sum of individual items; ranged from 0 to 16. Higher score indicated worst outcome. A negative change in score showed improvement.
The HAM-A was an investigator-administered scale and consisted of 14 items: anxious mood, tension, fears, insomnia, concentration, depressed mood, behavior at interview, somatic muscular, somatic sensory, cardiovascular, respiratory, gastrointestinal, genitourinary, and autonomic symptoms. Each item was scored on a scale of 0 (not present) to 4 (severe) with a total score range of 0-56. A decreased score indicated a decrease in anxiety symptoms.
The ADAS-Cog is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing a letter in an envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions were also obtained. The test was scored in terms of errors on a scale ranging from 0 (best) to 70 (worse), with higher scores indicate poorer performance and greater impairment.
The CDR-sum of boxes is a validated composite rating of cognition and everyday functioning used in longitudinal AD research which incorporates both informant input and direct assessment of performance. It assesses through semi-structured interview 3 cognitive domains including memory, orientation, and judgement/problem solving and 3 everyday functional domains including community affairs, home and hobbies and personal care. The individual domain score ranging from 0 (none) to 3 (severe) but the scores in each of these were combined to obtain a composite score (sum of boxes) ranging from 0 (best) to 18 (worst), with higher scores indicate poorer performance and greater impairment. The individual domain scores are added to create a sum of the box scores.
The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.
The severity of ataxia was assessed with the SARA, an 8-item clinical rating scale from 0 (no ataxia) to 40 (most severe ataxia). The total score was derived as the sum of the individual items, which included gait (0-8), stance (0-6), sitting (0-4), speech disturbance (0-6), finger chase (0-4), nose-finger test (0-4), fast alternating hand movements (0-4), and heel-shin slide (0-4). Since the finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide were repeated on both the right and left side, the average of the right and left side assessments was used to derive the total score. A negative change in score shows improvement.
Data will be summarized using descriptive statistics to compare between participants who received presurgical troriluzole and who did not
| Arm | Type | Description |
|---|---|---|
| Troriluzole | EXPERIMENTAL | Participants received troriluzole 200 milligrams (mg) (100 mg\*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg\*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. |
| BHV-4157 | EXPERIMENTAL | troriluzole, 280 mg (2 x 140 mg) capsules, QD |
| Troriluzole - Randomization Phase | EXPERIMENTAL | Troriluzole - Randomization Phase: Participants received Troriluzole 140 mg capsules orally once daily (QD) for 8 weeks. |
| Placebo - Randomization Phase | PLACEBO_COMPARATOR | Placebo - Randomization Phase: Participants received matching placebo capsules orally QD for 8 weeks. |
| Troriluzole/Troriluzole - OLE (Open Label Extension) Phase | EXPERIMENTAL | Participants received Troriluzole 140 mg capsules orally QD for 48 weeks in the extension period and were allowed to participate in 288 weeks for expanded extension phase, for a total of 336 weeks of open-label treatment. |
| Placebo/Troriluzole - OLE Phase | EXPERIMENTAL | Participants who received placebo during randomization phase, received Troriluzole 140 mg capsules orally QD for 48 weeks in the extension period and were allowed to participate in 288 weeks for expanded extension phase, for a total of 336 weeks of open-label treatment. |
| Group A: Presurgical Troriluzole | EXPERIMENTAL | 18 participants will be randomly assigned to this group and with complete: * Baseline visit with assessments and MRI. * Cycle 0: * Day -6 through Day 0: Predetermined dose of Troriluzole 2x daily. * Day 0: pre-op MRI * Day 0: standard of care surgical resection of tumor * Day 0: post-op MRI * Cycle 1 through Cycle 3: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * Cycle 3 through End of Treatment: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * MRIs every 8 weeks while on treatment. * End of study visit with MRI * Follow up every 3 months for 1 year, and then every 6 months for the next 3 years. |
| Group B: Surgery + Troriluzole | EXPERIMENTAL | 9 participants will be randomly assigned to this group and with complete: * Baseline visit with assessments and MRI * Day 0: pre-op MRI * Day 0: standard of care surgical resection of tumor * Day 0: post-op MRI * Cycle 1 through Cycle 3: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * Cycle 3 through End of Treatment: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * MRIs every 8 weeks while on treatment. * End of study visit with MRI * Follow up every 3 months for 1 year, and then every 6 months for the next 3 years. |
| Name | Type | Description |
|---|---|---|
| Troriluzole | DRUG | Capsules for oral administration. |
| Placebo | DRUG | Drug- matching capsules for oral administration. |
| Placebo oral capsule | DRUG | Oral matching placebo will be given daily for up to 48 weeks |
Key Inclusion Criteria: 1. Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening; the duration of the participants illness must be ≥ 1year 2. An inadequate response t...
Troriluzole is an investigational small molecule developed by Biohaven Ltd. (BHVN) for neurology indications. It is being studied in Alzheimer disease, generalized anxiety disorder, glioblastoma, obsessive-compulsive disorder, and spinocerebellar ataxias. It is not approved and remains in clinical development.
Troriluzole targets glutamate. It is a small molecule designed to modulate glutamate, the primary excitatory neurotransmitter in the central nervous system. This glutamate-targeting approach underlies its study across neurologic and psychiatric conditions, including obsessive-compulsive disorder, generalized anxiety disorder, and glioblastoma.
Biohaven Ltd., which trades under the ticker BHVN, is developing troriluzole. The company is the sponsor of the clinical program evaluating the drug across several neurologic and psychiatric indications.
Troriluzole is in Phase 2 development overall and is investigational. Its clinical program includes completed Phase 3 trials in obsessive-compulsive disorder and generalized anxiety disorder, plus an early Phase 1 surgical window trial in recurrent IDH wild-type glioblastoma that is currently recruiting.
Troriluzole has been studied in NCT06552260, an early Phase 1 surgical window trial in recurrent IDH wild-type glioblastoma that is recruiting, and in completed trials NCT04693351 and NCT04641143 in obsessive-compulsive disorder and NCT03829241 in generalized anxiety disorder. Total enrollment across these studies is 1,471 participants.
Troriluzole is not approved and is investigational. It remains in clinical development, with completed Phase 3 trials in obsessive-compulsive disorder and generalized anxiety disorder and an active early Phase 1 trial in recurrent IDH wild-type glioblastoma.