18 completed, 2 terminated, 2 withdrawn, 1 active not recruiting. 11 Phase 1, 8 Phase 2, 4 Phase 3, 2 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 11 |
| Phase 2 | 8 | Completed 4, Active not recruiting 1, Terminated 1, Unknown 1, Withdrawn 1 |
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Not applicable | 2 | Completed 2 |
| Phase 4 | 1 | Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults BIOPIN-6 Active Implant with Naltrexone, BIOPIN-6 Placebo Implant - Opioid Use Disorder | Phase 1 | Completed | Akyso Therapeutics, LLC | 16 | 2024-06-24 | 2026-04-28 |
| A Study of ANAVEX3-71 in Adults With Schizophrenia ANAVEX3-71 oral capsules, Placebo oral capsules - Schizophrenia | Phase 2 | Active not recruiting | Anavex Life Sciences Corp. | 71 | 2024-03-15 | 2025-05-04 |
| Phase I Single Ascending Dose and Multiple Ascending Doses of Oral AFA-281 in Healthy Volunteers AFA-281 - Pain, Neuropathic, Pain, Inflammatory | Phase 1 | Completed | Afasci Inc | 64 | 2023-04-11 | 2025-10-21 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) BXCL501, Matching Placebo - Agitation, Dementia | Phase 3 | Terminated | BioXcel Therapeutics Inc | 13 | 2022-12-05 | 2026-10-01 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) BXCL501, Matching Placebo - Agitation, Dementia | Phase 3 | Completed | BioXcel Therapeutics Inc | 151 | 2022-04-27 | 2026-08-11 |
| An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia BXCL501, Placebo film - Agitation, Dementia | Phase 2 | Terminated | BioXcel Therapeutics Inc | 5 | 2022-02-08 | 2026-08-11 |
| Safety and Efficacy of HB-1 for Panic Disorder HB-01, Placebo - Panic Disorder | Phase 2 | Completed | HB BioTech, LLC | 86 | 2022-02-03 | 2025-03-18 |
| Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim Placebo (Lactose) Capsule, 0.75 mg Alprazolam Capsule, Cannabis (6.18% THC / <0.025% CBD) - Driving Behavior, Driving Under the Influence | Phase 1 | Completed | Timothy L. Brown | 13 | 2021-07-16 | 2023-07-25 |
| Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain PPP001, Morphine sulfate or Hydromorphone or Oxycodone - Cancer, Breakthrough Cancer Pain | Phase 2 | Unknown | Tetra Bio-Pharma | 20 | 2021-05-26 | 2021-07-28 |
| Study of BXCL501 In Agitation Associated With Delirium in ICU Patients BXCL501, Placebo film - Agitation, Delirium | Phase 2 | Withdrawn | BioXcel Therapeutics Inc | 2021-02-23 | 2026-08-11 | |
| Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal Dexmedetomidine, Placebo - Opioid Withdrawal | Phase 1 / Phase 2 | Completed | BioXcel Therapeutics Inc | 225 | 2020-06-09 | 2026-08-11 |
| Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film - Agitation Associated With Bipolar Disorder, Agitation,Psychomotor | Phase 3 | Completed | BioXcel Therapeutics Inc | 380 | 2020-02-24 | 2026-08-11 |
| Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia Sublingual film containing dexmedetomidine (BXCL501), Placebo Film - Agitation, Schizophrenia | Phase 3 | Completed | BioXcel Therapeutics Inc | 380 | 2020-01-24 | 2026-08-11 |
| Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia Sublingual film containing Dexmedetomidine, Sublingual Placebo Film - Agitation,Psychomotor, Dementia | Phase 1 / Phase 2 | Completed | BioXcel Therapeutics Inc | 100 | 2019-12-27 | 2026-08-11 |
| A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia CTP-692, Placebo - Schizophrenia | Phase 2 | Completed | Concert Pharmaceuticals | 326 | 2019-11-26 | 2023-12-22 |
| Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia Sublingual film containing BXCL501 (Dexmedetomidine), Placebo film - Agitation, Schizophrenia | Phase 1 | Completed | BioXcel Therapeutics Inc | 135 | 2019-05-22 | 2026-08-11 |
| Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS BHV-0223 - Amyotrophic Lateral Sclerosis, ALS | Phase 1 | Completed | Biohaven Pharmaceuticals, Inc. | 22 | 2018-02-02 | 2022-10-06 |
| Driving Simulation to Assess Non-Sedative Effects of Tolperisone Cyclobenzaprine 10 Mg Oral Tablet, Placebo Oral Tablet - Driving Impaired | Phase 1 | Completed | Neurana Pharmaceuticals, Inc. | 35 | 2017-07-31 | 2022-02-01 |
| The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants Lasmiditan, Alprazolam, Placebo - Migraine | Phase 1 | Completed | Eli Lilly and Company | 90 | 2017-01-16 | 2020-01-10 |
| Pharmacokinetic Study of Intranasal RX0041-002 in Hepatic-Impaired Individuals and Subjects With Normal Hepatic Function RX0041-002 - Analgesic Allergy | Phase 1 | Completed | Pharmaceutical Project Solutions, Inc. | 24 | 2016-02-01 | 2018-09-06 |
Showing 20 of 24. Sign in to see all of them.
Psychomotor Agitation (9) · Dementia (4) · Schizophrenia (4) · Opioid-Related Disorders (2) · Amyotrophic Lateral Sclerosis (1) · Bipolar Disorder (1) · Delirium (1) · Driving Under the Influence (1) · Marijuana Abuse (1) · Mental Disorders (1) · Migraine Disorders (1) · Morphine Dependence (1) · Neoplasms (1) · Neuralgia (1) · Nocturia (1)
Dexmedetomidine (8) · Alprazolam (2) · Bulk Drugs (1) · Capsules (1) · Dronabinol (1) · FG 0041 (1) · Hydromorphone (1) · Lactose (1) · Morphine (1) · Naltrexone (1) · Oxycodone (1) · Tablets (1) · cyclobenzaprine (1) · darifenacin (1) · lasmiditan (1)
United States (22) · Canada (1)
BioXcel MM, MD (7) · BioXcel MM (1) · Chad VanDenBerg, Pharm.D. (1) · David Walling (1) · Gary Kay, PhD (1) · Mitchell Hassman (1) · Robert Risinger, MD (1) · Timothy L Brown (1) · Todd Bertoch, MD (1) · Xinmin Xie, MD, PhD (1)
PMID 36002761, PMID 35191924, PMID 36198061, PMID 36280451
5UG3DA048338-02 (1)