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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04066088
• Date of registration: 21/08/2019
• Prospective Registration: Yes
• Primary sponsor: NYU Langone Health
• Public title: Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
• Scientific title: Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
• Date of first enrolment: December 1, 2019
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT04066088
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Deepan Singh, MD
• Affiliation: New York Langone Health

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 6 Years
Age maximum: 35 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Intervention(s)

Other: Placebo

Drug: Guanfacine extended release (GXR)

Primary Outcome(s)

CGI-I scale rating [Time Frame: 19 Weeks]

Secondary Outcome(s)

Modified Overt Aggression Scale [Time Frame: 19 Weeks]

Aberrant Behavior Checklist [Time Frame: 19 Weeks]

Self-Injury Trauma scale [Time Frame: 19 Weeks]

Secondary ID(s)

19-00936

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Winthrop University Hospital