9 completed, 3 terminated, 1 not yet recruiting. 7 Phase 2, 4 Phase 3, 2 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 5, Terminated 2 |
| Phase 3 | 4 | Completed 2, Terminated 2 |
| Phase 1 | 2 | Completed 2 |
| Not applicable | 1 | Not yet recruiting 1 |
Follow trofinetide: new trials by email Literature Review of trofinetide trials Research Report on trofinetide
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 |
|---|---|---|---|---|---|---|
| Adapting a Psychosocial Support Intervention for the Rett Syndrome Community Those who have patients prescribed Daybue, Caregiver Speaks + Daybue - Rett Syndrome, Family Caregivers | Not applicable | Not yet recruiting | Colorado State University | 60 | 2026-08-01 | 2026-07-28 |
| An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome Trofinetide - Rett Syndrome | Phase 2 / Phase 3 | Terminated | ACADIA Pharmaceuticals Inc. | 15 | 2021-09-22 | 2024-09-24 |
| Open-Label Extension Study of Trofinetide for Rett Syndrome trofinetide - Rett Syndrome | Phase 3 | Terminated | ACADIA Pharmaceuticals Inc. | 77 | 2020-11-08 | 2024-09-27 |
| Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome Trofinetide - Rett Syndrome | Phase 3 | Completed | ACADIA Pharmaceuticals Inc. | 154 | 2020-01-29 | 2024-04-11 |
| Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™) Trofinetide, Placebo - Rett Syndrome | Phase 3 | Completed | ACADIA Pharmaceuticals Inc. | 187 | 2019-11-06 | 2024-04-08 |
| A Safety Study of NNZ-2566 in Pediatric Rett Syndrome NNZ-2566, Placebo - Rett Syndrome | Phase 2 | Completed | Neuren Pharmaceuticals Limited | 82 | 2016-03-01 | 2020-08-14 |
| A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI) NNZ-2566, Placebo - Concussion | Phase 2 | Terminated | Neuren Pharmaceuticals Limited | 32 | 2014-09-01 | 2018-02-05 |
| A Safety Study of NNZ-2566 in Patients With Fragile X Syndrome NNZ-2566, Placebo - Fragile X Syndrome | Phase 2 | Completed | Neuren Pharmaceuticals Limited | 72 | 2014-01-01 | 2018-02-05 |
| A Safety Study of NNZ-2566 in Patients With Rett Syndrome NNZ-2566, Placebo - Rett Syndrome | Phase 2 | Completed | Neuren Pharmaceuticals Limited | 67 | 2013-03-01 | 2018-02-05 |
| Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC NNZ-2566, Placebo - Brain Injuries | Phase 2 | Completed | Neuren Pharmaceuticals Limited | 261 | 2013-02-01 | 2018-02-05 |
| Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration NNZ-2566, Placebo - Brain Injuries, Traumatic | Phase 1 | Completed | Neuren Pharmaceuticals Limited | 24 | 2012-02-01 | 2012-11-22 |
| Study of NNZ-2566 in Patients With Traumatic Brain Injury NNZ-2566, Placebo - Brain Injuries | Phase 2 | Completed | Neuren Pharmaceuticals Limited | 261 | 2010-04-01 | 2018-02-05 |
| Safety Study of NNZ-2566 in Healthy Female Subjects NNZ-2566, Placebo - Brain Injuries, Traumatic | Phase 1 | Completed | Neuren Pharmaceuticals Limited | 39 | 2010-03-01 | 2014-10-07 |
Rett Syndrome (7) · Autistic Disorder (3) · Ataxia (2) · Brain Injuries (2) · Brain Injuries, Traumatic (2) · Brain Concussion (1) · Fragile X Syndrome (1)
Neuren Pharmaceuticals Limited (8) · ACADIA Pharmaceuticals Inc. (4) · Colorado State University (1)
United States (11) · Australia (2)
Alan Percy, MD (2) · Ross R Bullock, M.D., PhD (2) · Steve Skinner, MD (2) · Timothy Feyma, MD (2) · Alex Hishaw, MD (1) · Alexander Kolevzon, MD (1) · Arthur Beisang, MD (1) · Brian O'Neil, MD (1) · Bryan King, MD (1) · Craig Erickson, MD (1) · Daniel G Glaze, M.D. (1) · Daniel Glaze, MD (1) · Diane Treadwell-Deering, MD (1) · Douglas J Wilson, MB ChB, PhD (1) · Elizabeth M Berry-Kravis, MD (1)
PMID 37460385, PMID 38363467, PMID 30624278, PMID 31198061, PMID 32660869, PMID 35149233, PMID 37291210, PMID 38917793, PMID 40043705