Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT04066088

Run by

NYU Langone Health

People needed

0

Starts

2019-12-01

Expected to finish

2020-08-21

Last updated by the study team

2020-08-26

Who can join

Age: 6 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 6 and 35 years of age
• diagnosis of PWS confirmed by genetic testing.
• rating of moderate or above on the Clinical Global Impression- Severity Scale will be required for entry.

You may not qualify if…

• Subjects with a positive pregnancy test, swallowing difficulty, and/or presenting with active psychosis or mania will be excluded.
• 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.
• 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.
• 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.

Where it is running

• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

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