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NCT03605667 · ClinicalTrials.gov registry record · Phase 2

Study of BHV-4157 in Alzheimer's Disease

A Phase 2 study of Alzheimer Disease, sponsored by Biohaven Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
350
Enrollment target
20
Study locations

NCT03605667 is a Phase 2 study of Alzheimer Disease that has completed, run by Biohaven Pharmaceuticals. The registered enrollment target is 350 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT03605667, a Phase 2 study of Alzheimer Disease, has completed, sponsored by Biohaven Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
350 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Alzheimer Disease

Interventions

  • DRUG Placebo oral capsule
  • DRUG troriluzole

Study Locations (20)

California

  • Neurology Center of North Orange County - Fullerton
  • University of California, San Diego - La Jolla
  • University of Southern California - Los Angeles
  • SC3 Research Group - Pasadena - Pasadena

Arizona

  • Xenoscience, Inc. - Phoenix
  • Barrow Neurological Institute - Phoenix
  • Banner Sun Health Research Institute - Sun City

Connecticut

  • Geriatric and Adult Psychiatry - Hamden
  • Yale University School of Medicine - New Haven
  • Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH - Stamford

Florida

  • Brain Matters Research - Delray Beach
  • University of Miami - Miami
  • USF Health Byrd Alzheimer's Institute - Tampa

Illinois

  • Northwestern University - Chicago
  • Great Lakes Clinical Trials - Chicago
  • Southern Illinois University - Springfield

Indiana

  • Indiana University - Indianapolis

Iowa

  • University of Iowa - Iowa City

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2018-07-31
Est. Completion 2021-12-23
Phase Phase 2

Sponsor

Biohaven Pharmaceuticals

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03605667

The ClinicalTrials.gov registry entry for NCT03605667 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (87% lower). The listed sponsor is Biohaven Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.

NCT03605667 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Arizona, Connecticut.

Frequently Asked Questions

What is clinical trial NCT03605667 about?

NCT03605667 is a clinical study titled "Study of BHV-4157 in Alzheimer's Disease". 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...

What is the current status of trial NCT03605667?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2018-07-31. Estimated completion is 2021-12-23.

What conditions does trial NCT03605667 study?

This clinical trial studies the following conditions: Alzheimer Disease.

What interventions are being tested in trial NCT03605667?

The interventions under investigation include: Placebo oral capsule (DRUG), troriluzole (DRUG).

Who is sponsoring clinical trial NCT03605667?

This trial is sponsored by Biohaven Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03605667 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.