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| Name | Class |
|---|---|
| Alzheimer's Disease Cooperative Study (ADCS) | OTHER |
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Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or placebo, were administered orally once daily. Duration of treatment is 48 weeks in double-blind phase. There is also a screening period of up to 42 days; and a 4-week post-treatment observation period. Eligible participants who completed the double-blind treatment phase had the opportunity to receive open-label troriluzole for up to 48 weeks in an open-label extension (OLE) phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-4157 | Experimental | troriluzole, 280 mg (2 x 140 mg) capsules, QD |
|
| Placebo | Placebo Comparator | matching 280 mg (2 x 140 mg) placebo capsules, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| troriluzole | Drug | Oral BHV-4157 will be given daily for up to 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 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. | Baseline (Day 1) and Week 48 |
| Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-Sum of Boxes) Total Score at Week 48 | 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. | Baseline (Day 1) and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 | Volumetric MRI allows the in vivo assessment of brain structure volume and provides a measure of atrophy rate. Results from MRI studies suggest that the patterns of atrophy in AD, which mirror the pathological progression of the disease, can reliably be detected and tracked across time. Hippocampal volume derived from MRI correlates with histological hippocampal volume and degree of neuronal loss and AD pathology, and entorhinal cortical thickness change appears to be an early and sensitive indicator of neurodegeneration associated with AD. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 in Mild Subgroup | Subgroup of participants MMSE Category = Mild. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicating more cognitive impairment. Mild are participants with a baseline MMSE score greater than or equal to 20. | Baseline (Day 1) and Week 48 |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xenoscience, Inc. | Phoenix | Arizona | 85004 | United States | ||
| Barrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40317057 | Derived | Qiu Y, Jacobs DM, Messer K, Salmon DP, Wellington CL, Stukas S, Revta C, Brewer JB, Leger GC, Askew B, Donahue L, Kaplita S, Coric V, Qureshi IA, Feldman HH; Alzheimer's Disease Cooperative Study T2 Protect AD Study Group. Prognostic value of plasma biomarkers for informing clinical trial design in mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2025 May 2;17(1):97. doi: 10.1186/s13195-025-01745-3. |
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A total of 687 participants were screened, of which 350 participants were randomized in a 1:1 ratio to receive troriluzole or placebo. 337 participants were not randomized due to screen failure, adverse events, lost to follow-up, withdrawal of consent, or unspecified reasons.
This Phase 2, randomized, double-blind, placebo-controlled study was conducted in participants with mild to moderate alzheimer's disease (AD) at 44 centers in the US between 31-Jul-2018 and 23-Dec-2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Troriluzole | Randomization phase (Randomization through Week 48): Participants received starting dose of troriluzole 140 milligrams (mg) capsules orally once daily for 2 weeks, followed by 280 mg once daily for the remaining 46 weeks of the double-blind phase. Open-label extension (OLE) phase (48 weeks): Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization Phase (Weeks 1 Through 48) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2020 | Oct 20, 2023 |
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| Placebo oral capsule | Drug | Oral matching placebo will be given daily for up to 48 weeks |
|
| Baseline (Day 1) and Week 48 |
| Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 48 | The ADCS-ADL inventory scale is validated questionnaire developed by the ADCS to assess instrumental and basic activities of daily living based on a 23-item structured interview of the AD study participant's partner. The scale ranging from 0 (none) to 78 (severe), with lower scores indicate greater impairment. | Baseline (Day 1) and Week 48 |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 48 | The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology in AD dementia based on the results of an interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric features, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability and lability, and aberrant motor behavior, as well as evaluates sleep and appetite/eating disorders. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously). Severity assessments range from 1 (mild) to 3 (severe). The total score is the sum of all subscales ranging from 1 (mild) to 7 (severe), with higher scores indicate greater impairment. | Baseline (Day 1) and Week 48 |
| Change From Baseline in Mini-Mental Status Examination (MMSE) Total Score at Week 48 | The MMSE is a frequently used screening instrument for AD drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy 2 intersecting pentagons. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicate more cognitive impairment. | Baseline (Day 1) and Week 48 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes. An AE is considered "Related" for causality designations of possible, probable and definite. | TEAEs were reported from first dose of study drug up to end of study treatment, maximum of 96 weeks. |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| University of California, San Diego | La Jolla | California | 92037 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| SC3 Research Group - Pasadena | Pasadena | California | 91105 | United States |
| Geriatric and Adult Psychiatry | Hamden | Connecticut | 06518 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH | Stamford | Connecticut | 06905 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| USF Health Byrd Alzheimer's Institute | Tampa | Florida | 33613 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Southern Illinois University | Springfield | Illinois | 62702 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kentucky | Lexington | Kentucky | 40504 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| Northern Light Acadia Hospital | Bangor | Maine | 04401 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| University of Michigan, Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Galen Research | Chesterfield | Missouri | 63005 | United States |
| Cleveland Clinic Lou Ruvo Center | Las Vegas | Nevada | 89106 | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14620 | United States |
| SUNY Upstate Medical University Department of Geriatrics | Syracuse | New York | 13202 | United States |
| James J. Peters VAMC | The Bronx | New York | 10468 | United States |
| Case Western Reserve University | Beachwood | Ohio | 44122 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Tulsa Clinical Research | Tulsa | Oklahoma | 74104 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 19403 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Geisinger Medical Clinic | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| CBRI, Roper Hospital | Charleston | South Carolina | 29401 | United States |
| Vanderbilt Memory & Alzheimer's Center | Nashville | Tennessee | 37212 | United States |
| The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases,University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| University of Washington | Seattle | Washington | 98108 | United States |
| FG001 | Placebo | Randomization phase (Randomization through Week 48): Participants received placebo matching with troriluzole for 48 weeks. OLE phase (48 weeks): Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| OLE Phase (48 Weeks) |
|
|
Treated population included enrolled and randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Troriluzole | Randomization phase (Randomization through Week 48): Participants received starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg once daily for the remaining 46 weeks of the double-blind phase. OLE phase (48 weeks): Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. |
| BG001 | Placebo | Randomization phase (Randomization through Week 48): Participants received placebo matching with troriluzole for 48 weeks. OLE phase (48 weeks): Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 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. | Modified Intent to Treat (mITT) population included randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo) and who also had a baseline assessment and who have at least 1 efficacy evaluation following baseline. Participants results at Week 48 are reported. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (Day 1) and Week 48 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-Sum of Boxes) Total Score at Week 48 | 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 mITT population included randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo) and who also had a baseline assessment and who have at least 1 efficacy evaluation following baseline. Participants results at Week 48 are reported. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (Day 1) and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 | Volumetric MRI allows the in vivo assessment of brain structure volume and provides a measure of atrophy rate. Results from MRI studies suggest that the patterns of atrophy in AD, which mirror the pathological progression of the disease, can reliably be detected and tracked across time. Hippocampal volume derived from MRI correlates with histological hippocampal volume and degree of neuronal loss and AD pathology, and entorhinal cortical thickness change appears to be an early and sensitive indicator of neurodegeneration associated with AD. | The mITT population included randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo) and who also had a baseline assessment and who have at least 1 efficacy evaluation following baseline. Participants results at Week 48 are reported. | Posted | Least Squares Mean | 95% Confidence Interval | percent deformation | Baseline (Day 1) and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 48 | The ADCS-ADL inventory scale is validated questionnaire developed by the ADCS to assess instrumental and basic activities of daily living based on a 23-item structured interview of the AD study participant's partner. The scale ranging from 0 (none) to 78 (severe), with lower scores indicate greater impairment. | The mITT population included randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo) and who also had a baseline assessment and who have at least 1 efficacy evaluation following baseline. Participants results at Week 48 are reported. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (Day 1) and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 48 | The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology in AD dementia based on the results of an interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric features, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability and lability, and aberrant motor behavior, as well as evaluates sleep and appetite/eating disorders. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously). Severity assessments range from 1 (mild) to 3 (severe). The total score is the sum of all subscales ranging from 1 (mild) to 7 (severe), with higher scores indicate greater impairment. | The mITT population included randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo) and who also had a baseline assessment and who have at least 1 efficacy evaluation following baseline. Participants results at Week 48 are reported. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (Day 1) and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mini-Mental Status Examination (MMSE) Total Score at Week 48 | The MMSE is a frequently used screening instrument for AD drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy 2 intersecting pentagons. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicate more cognitive impairment. | The mITT population included randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo) and who also had a baseline assessment and who have at least 1 efficacy evaluation following baseline. Participants results at Week 48 are reported. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (Day 1) and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes. An AE is considered "Related" for causality designations of possible, probable and definite. | Treated population included enrolled and randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). | Posted | Count of Participants | Participants | No | TEAEs were reported from first dose of study drug up to end of study treatment, maximum of 96 weeks. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 in Mild Subgroup | Subgroup of participants MMSE Category = Mild. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicating more cognitive impairment. Mild are participants with a baseline MMSE score greater than or equal to 20. | Posted | Least Squares Mean | 95% Confidence Interval | percent deformation | Baseline (Day 1) and Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Responders in Participants With ADAS-cog Total Change and MRI Hippocampal Volume Change at Week 48 in Mild APOE e4 Carrier Subgroup | Mild APOE e4 carrier subgroup are participants with a baseline MMSE score greater than or equal to 20 with APOE e4 genotype. Responder based on ADAS-cog Total Change less than or equal to 1 and MRI Hippocampal Volume Change greater than or equal to -2.09. ADAS-cog change and MRI Hippcampal volume change criteria based on 25th percentile. | Posted | Count of Participants | Participants | Baseline (Day 1) and Week 48 |
|
|
TEAEs were reported from first dose of study drug up to end of study treatment, maximum of 96 weeks.
Treated population included enrolled and randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Troriluzole - Randomization Phase | Participants received starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg once daily for the remaining 46 weeks of the double-blind phase. | 2 | 178 | 24 | 178 | 81 | 178 |
| EG001 | Placebo - Randomization Phase | Participants received placebo matching with troriluzole for 48 weeks. | 2 | 171 | 14 | 171 | 53 | 171 |
| EG002 | Troriluzole - Randomization Phase/ Troriluzole - OLE Phase | Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. | 0 | 90 | 9 | 90 | 29 | 90 |
| EG003 | Placebo - Randomization Phase/ Troriluzole - OLE Phase | Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. | 2 | 103 | 16 | 103 | 31 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pelvic mass | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Frostbite | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Embolic cerebral infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neuropsychiatric symptoms | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Somnambulism | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
All participants in the OLE phase underwent a termination visit 2 weeks after the last dose of troriluzole.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Biohaven Pharmaceuticals, Inc | +1 203-404-0410 | clinicaltrials@biohavenpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2020 | Oct 20, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Lack of Efficacy |
|
| Adverse Event |
|
| Progressive Disease |
|
| Physician Decision |
|
| Protocol Violation |
|
| Study Terminated By Sponsor |
|
| Death |
|
| Lost to Follow-up |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Unstructure covariance structure.
Randomization phase (Randomization through Week 48): Participants received placebo matching with troriluzole for 48 weeks. |
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| Units |
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| Counts |
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Randomization phase (Randomization through Week 48): Participants received placebo matching with troriluzole for 48 weeks. |
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| Units |
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| Counts |
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| Participants |
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Participants received placebo matching with troriluzole for 48 weeks. |
| OG002 | Troriluzole - Randomization Phase/ Troriluzole - OLE Phase | Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. |
| OG003 | Placebo - Randomization Phase/ Troriluzole - OLE Phase | Participants who completed the double-blind treatment phase were offered the opportunity to enroll in an OLE phase to receive starting dose of troriluzole 140 mg capsules orally once daily for 2 weeks, followed by 280 mg orally once daily for the remaining 46 weeks. |
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