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- |||||||| intranasal carbetocin (ACP-101) / Acadia Pharma
New P3 trial: OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome (clinicaltrials.gov) - May 20, 2024
P3, N=160, Enrolling by invitation, Sponsor: ACADIA Pharmaceuticals Inc.
- ||| intranasal carbetocin (LV-101) / Levo Therap
P3 data, Journal: Intranasal Carbetocin Reduces Hyperphagia, Anxiousness and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial. (Pubmed Central) - Jun 19, 2023
P3
Carbetocin was well tolerated, and the 3.2-mg dose was associated with clinically meaningful improvements in hyperphagia and anxiousness and distress behaviors in participants with PWS.
- | intranasal carbetocin (LV-101) / Levo Therap
Journal: The Prader-Willi Syndrome Anxiousness and Distress Behaviors Questionnaire: Development and Psychometric Validation. (Pubmed Central) - Oct 8, 2022
Carbetocin was well tolerated, and the 3.2-mg dose was associated with clinically meaningful improvements in hyperphagia and anxiousness and distress behaviors in participants with PWS. The current body of evidence supports the conclusion that the PADQ measures observable behaviors that are meaningful to patients and their families and provides a valid and reliable method to assess beneficial treatment effects for some of the most challenging behaviors associated with PWS.
- ||||| intranasal carbetocin (ACP-101) / Acadia Pharma
Trial completion, Trial completion date: CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - Jul 26, 2022
P3, N=130, Completed, Sponsor: Levo Therapeutics, Inc.
The current body of evidence supports the conclusion that the PADQ measures observable behaviors that are meaningful to patients and their families and provides a valid and reliable method to assess beneficial treatment effects for some of the most challenging behaviors associated with PWS. Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jul 2022
- || intranasal carbetocin (ACP-101) / Acadia Pharma
Trial completion date: CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - Aug 18, 2021
P3, N=130, Active, not recruiting, Sponsor: Levo Therapeutics, Inc.
Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jul 2022 Trial completion date: Jun 2021 --> Dec 2022
- intranasal carbetocin (LV-101) / Levo Therap
[VIRTUAL] Topline Results of the CARE-PWS Phase 3 Study: Intranasal Carbetocin Improves Hyperphagia and Anxiety and Distress Symptoms in Prader-Willi Syndrome (PWS) (Live) - Feb 2, 2021 - Abstract #ENDO2021ENDO_389;
For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- |||| intranasal carbetocin (ACP-101) / Acadia Pharma
Enrollment closed: CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - Jun 1, 2020
P3, N=175, Active, not recruiting, Sponsor: Levo Therapeutics, Inc.
The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021. Suspended --> Active, not recruiting
- ||||||| intranasal carbetocin (ACP-101) / Acadia Pharma
Trial suspension: CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - Apr 19, 2020
P3, N=175, Suspended, Sponsor: Levo Therapeutics, Inc.
Suspended --> Active, not recruiting Recruiting --> Suspended
- ||| intranasal carbetocin (ACP-101) / Acadia Pharma
Trial completion date, Trial primary completion date: CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - Jan 18, 2020
P3, N=175, Recruiting, Sponsor: Levo Therapeutics, Inc.
Recruiting --> Suspended Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Dec 2019 --> Jun 2020
- | intranasal carbetocin (ACP-101) / Acadia Pharma
Enrollment open: CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - Nov 20, 2018
P3, N=175, Recruiting, Sponsor: Levo Therapeutics, Inc.
Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Dec 2019 --> Jun 2020 Not yet recruiting --> Recruiting
- | intranasal carbetocin (ACP-101) / Acadia Pharma
New P3 trial: CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - Aug 28, 2018
P3, N=175, Not yet recruiting, Sponsor: Levo Therapeutics, Inc.