Your session is about to expire
← Back to Search
Alpha-2A Adrenergic Receptor Agonist
Guanfacine Extended Release for Prader-Willi Syndrome (PWS-GXR Trial)
Phase 4
Recruiting
Led By Deepan Singh, MD
Research Sponsored by Maimonides Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
PWS-GXR Trial Summary
This trial will study if a medication can reduce aggressive and self-harming behavior in people with PWS, and its safety, esp. its metabolic effects.
Who is the study for?
This trial is for individuals with Prader-Willi Syndrome who show moderate or severe aggression and self-harm, confirmed by genetic testing. It's not for those pregnant, with swallowing issues, psychosis, mania, lactose intolerance, low heart rate or blood pressure.Check my eligibility
What is being tested?
The study tests if Guanfacine Extended Release (GXR) can reduce aggression and self-injury in Prader-Willi Syndrome patients compared to a placebo. The trial also looks at GXR's safety regarding metabolic effects.See study design
What are the potential side effects?
Potential side effects of GXR may include drowsiness, headache, stomach pain, nausea; less commonly slow heart rate (bradycardia), low blood pressure (hypotension), and possibly metabolic changes.
PWS-GXR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Global Impression- Improvement change from baseline to week 16
Secondary outcome measures
A change in Aberrant Behavior Checklist from baseline to week 16
A change in Modified Overt Aggression Scale from baseline to week 16
A change in Self-Injury Trauma Scale from baseline to week 16
Side effects data
From 2011 Phase 4 trial • 42 Patients • NCT0106952331%
Sedation
19%
Fatigue
6%
Stomachache
6%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guanfacine Extended Release
Placebo
PWS-GXR Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GXRExperimental Treatment1 Intervention
Immediately following the 8-week blinded randomized trial, an 8-week open-label continuation phase will be pursued to further define efficacy and tolerability of GXR, and to establish its safety with specific focus on metabolic profile.
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guanfacine Extended Release
2010
Completed Phase 4
~50
Find a Location
Who is running the clinical trial?
Maimonides Medical CenterLead Sponsor
69 Previous Clinical Trials
15,262 Total Patients Enrolled
1 Trials studying Prader-Willi Syndrome
30 Patients Enrolled for Prader-Willi Syndrome
Deepan Singh, MDPrincipal InvestigatorMaimonides Medical Center
4 Previous Clinical Trials
152 Total Patients Enrolled
3 Trials studying Prader-Willi Syndrome
132 Patients Enrolled for Prader-Willi Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allowed to continue taking growth hormone, thyroid hormone replacement, and non-psychiatric medications.You have been rated as moderately or severely affected on the Clinical Global Impression- Severity Scale.- You are pregnant according to a positive pregnancy test.
- You have trouble swallowing.
- You are currently experiencing severe mental health issues such as active psychosis or mania.You are unable to digest lactose.
Research Study Groups:
This trial has the following groups:- Group 1: GXR
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are juveniles of a certain age qualified to participate in this experiment?
"This research is open to applicants aged between 6 and 35 years old."
Answered by AI
Who has the opportunity to take part in this examination?
"To qualify for this medical trial, applicants must have a neurodegenerative disease and be between 6-35 years old. 33 individuals are accepted in total."
Answered by AI
Has GXR attained regulatory clearance from the FDA?
"Our assessment at Power rates the safety of GXR as a 3, since this is an approved Phase 4 trial which has already been deemed safe for general use."
Answered by AI
What is the overall size of this research project's participant pool?
"Affirmative. Clinicaltrials.gov showcases that this medical trial is currently looking for participants; the initial posting was on December 17th 2020 and there has since been a recent update on December 12th 2022. This study requires recruitment of 33 individuals from 1 location."
Answered by AI
Are there any vacancies for participation in this trial?
"Affirmative, clinicaltrials.gov data indicates that this medical trial is presently in search of participants. Begun on December 17th 2020 and most recently updated on the 12th of December 2022, 33 patients are being invited to join from a single facility."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger