NCT05657860CompletedPhase 4
Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
A Double Blind, Placebo Controlled, Fixed-Flexible Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
Source: ClinicalTrials.gov · Last updated 19 Aug 2024
Brief summary (registry, in English)
This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS). In addition, the study will establish the safety of GXR with a specific focus on metabolic effects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 12 Dec 2022
- Start date
- 17 Dec 2020
- Primary completion date
- 16 Dec 2023
- Lead sponsor
- Maimonides Medical Center
- Diseases
- Obesity
- NCT number
- NCT05657860
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 15
- From 17 Dec 2020 to the primary completion date, 16 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects currently taking guanfacine extended release
- Subjects receiving antipsychotic medications due to a documented history of psychosis or bipolar disorder will be allowed to continue taking the medication without dosage modification.
Other illness
- Growth hormone, thyroid hormone replacement treatment, and non-psychiatric medicines will be allowed to continue.
- N-Acetyl Cysteine and anticonvulsant medication (only if prescribed for seizures) will be allowed to continue, with specific instructions to not make any dosage changes during the clinical trial.
Age
- Individuals with pre-existing, clinically significant bradycardia (\< 8 years: \<64 bpm; 8 to 12 years: \<59 bpm; 12 to 16 years: \<53 bpm) or hypotension, defined as 5th percentile for height and gender,26 will be excluded from the study.
Other
- Subjects with positive pregnancy test, swallowing difficulty, and/or presenting with active psychosis or mania will be excluded
- Patients with lactose intolerance
Who the study is looking for
- Diagnosis of PWS confirmed by genetic testing documentation
- Rating of moderate or above on the Clinical Global Impression- Severity Scale
Age in the registry: 6 years to 35 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maimonides Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.