5 completed, 3 terminated, 2 unknown. 6 Phase 2, 5 Phase 3, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 3, Terminated 2, Unknown 1 |
| Phase 3 | 5 | Terminated 3, Completed 1, Unknown 1 |
| Phase 1 | 4 | Completed 4 |
Follow 2-Hydroxypropyl-beta-cyclodextrin: new trials by email Literature Review of 2-Hydroxypropyl-beta-cyclodextrin trials Research Report on 2-Hydroxypropyl-beta-cyclodextrin
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 |
|---|---|---|---|---|---|---|
| A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease Hydroxypropyl Beta Cyclodextrin, Placebo - Alzheimer's Disease | Phase 2 | Unknown | Cyclo Therapeutics, Inc. | 90 | 2022-09-23 | 2023-04-25 |
| Phase 3 Study to Evaluate Intravenous Trappsol(R) Cyclo(TM) in Pediatric and Adult Patients With Niemann-Pick Disease Type C1 Hydroxypropyl-beta-cyclodextrin, Placebo - Niemann-Pick Disease, Type C1 | Phase 3 | Unknown | Cyclo Therapeutics, Inc. | 94 | 2021-07-20 | 2024-06-04 |
| Open-label Study of VTS-270 in Participants With Neurologic Manifestations of Niemann-Pick Type C1 VTS-270 - Niemann-Pick Disease, Type C | Phase 2 / Phase 3 | Terminated | Mandos LLC | 2 | 2019-12-02 | 2023-12-26 |
| Study of IV VTS-270 for Infantile Liver Disease Associated With Niemann-Pick Disease, Type C VTS-270 - Niemann-Pick Disease, Type C | Phase 1 / Phase 2 | Completed | Washington University School of Medicine | 4 | 2019-02-22 | 2026-01-05 |
| Niemann-Pick Type C Treatment With Adrabetadex for Symptoms of Brain and Nervous System Adrabetadex - Niemann-Pick Type C Disease | Phase 3 | Terminated | Mandos LLC | 27 | 2018-06-18 | 2024-01-17 |
| Study of the Pharmacokinetics of Trappsol and Effects on Potential Biomarkers of Niemann-Pick C1 (NPC1) Hydroxypropyl-beta-cyclodextrin - Niemann-Pick Disease, Type C1 | Phase 1 | Completed | Cyclo Therapeutics, Inc. | 13 | 2017-10-11 | 2021-02-21 |
| Safety and Efficacy of Intravenous Trappsol Cyclo (HPBCD) in Niemann-Pick Type C Patients Hydroxypropyl-beta-cyclodextrin - Niemann-Pick Disease, Type C1 | Phase 1 / Phase 2 | Completed | Cyclo Therapeutics, Inc. | 12 | 2017-03-20 | 2021-08-10 |
| Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease Adrabetadex - Niemann-Pick Disease, Type C | Phase 2 / Phase 3 | Terminated | Mandos LLC | 66 | 2015-12-23 | 2023-08-29 |
| VTS-270 to Treat Niemann-Pick Type C1 (NPC1) Disease Parts A/B: Adrabetadex, Parts A/B: Sham Control - Niemann-Pick Disease, Type C | Phase 2 / Phase 3 | Completed | Mandos LLC | 56 | 2015-10-01 | 2023-02-22 |
| Hydroxypropyl Beta Cyclodextrin for Niemann-Pick Type C1 Disease VTS-270 - Niemann-Pick Disease, Type C1 | Phase 1 | Completed | Vtesse, LLC, a Mallinckrodt Pharmaceuticals Company | 14 | 2013-01-01 | 2021-07-23 |
Niemann-Pick Disease, Type C (9) · Cognitive Dysfunction (2) · Deglutition Disorders (2) · Disease (2) · Mobility Limitation (2) · Alzheimer Disease (1) · Nerve Degeneration (1)
Cyclo Therapeutics, Inc. (4) · Mandos LLC (4) · Vtesse, LLC, a Mallinckrodt Pharmaceuticals Company (1) · Washington University School of Medicine (1)
United States (8) · United Kingdom (4) · Australia (3) · Germany (3) · Turkey (Türkiye) (3) · France (2) · Israel (2) · New Zealand (2) · Singapore (2) · Spain (2) · Argentina (1) · Brazil (1) · Costa Rica (1) · Italy (1) · Poland (1)
Karen Mullen, MD (2) · Caroline Hastings, MD (1) · Patricia I Dickson, MD (1) · Reena Sharma, MB BS (1)
PMID 36279795, PMID 40525490, PMID 31187454, PMID 34810067, PMID 37670901
2015 (2), U01HD090845 (1)