Status:
WITHDRAWN
Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Winthrop University Hospital
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
6-35 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Prader-Willi syndrome is a genetic disorder due to loss of function of specific genes. In newborns, symptoms include weak muscles, poor feeding, and slow development. Beginning in childhood, the perso...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04066088
Start Date
December 1 2019
End Date
August 21 2020
Last Update
August 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10016