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NCT04066088
Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
Phase 4 trial testing Placebo in Prader-Willi Syndrome. Withdrawn.
21 August 2020
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 December 2019 |
| Primary completion | 21 August 2020 |
| Estimated completion | 21 August 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Placebo
- Guanfacine extended release (GXR) — full drug profile →
Conditions studied
- Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 6 to 35, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a placebo-controlled clinical trial to assess the utility of Guanfacine Extended Release (GXR) in the management of patients with Prader Willi Syndrome (PWS) who have significant aggression or self-injury. The purpose of this trial is to establish the safety of GXR with a specific focus on metabolic effects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04066088
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prader-Willi Syndrome
Currently open trials in the same condition.
- NCT06877715 — Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome · recruiting
- NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT06239116 — A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · Phase 1, PHASE2 · recruiting
- NCT06144645 — A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS · Phase 3 · active not recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
- NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
- NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04066088 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 26 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04066088.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing