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CSTI-500 10mg for Prader-Willi Syndrome

Phase 1
Waitlist Available
Led By Italo Biaggioni, MD
Research Sponsored by ConSynance Therapeutics
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 pre-dose to 1, 2, 4, 8, 12, 24, 48, 72, and 144 hours post-dose
Awards & highlights

Study Summary

This trial studies the safety and how the body processes a new drug for Prader-Willi Syndrome in people 13-50.

Eligible Conditions
  • Prader-Willi Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose to 1, 2, 4, 8, 12, 24, 48, 72, and 144 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose to 1, 2, 4, 8, 12, 24, 48, 72, and 144 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-72
AUC0-inf
CSTI-500 plasma concentration
+1 more
Secondary outcome measures
Comparison of CSTI-500 AUC0-72 values obtained from venous blood draws with values obtained from finger prick samples in PWS subjects
Comparison of CSTI-500 AUC0-inf values obtained from venous blood draws with values obtained from finger prick samples in PWS subjects
Comparison of CSTI-500 Cmax values obtained from venous blood draws with values obtained from finger prick samples in PWS subjects
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CSTI-500 10mgExperimental Treatment1 Intervention
All eligible subjects will be administered a single oral dose of CSTI-500 10 mg at Visit 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSTI-500
2022
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

ConSynance TherapeuticsLead Sponsor
Italo Biaggioni, MDPrincipal InvestigatorVanderbilt Autonomic Dysfunction Center, Vanderbilt University Medical Center
28 Previous Clinical Trials
1,444 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence exists to demonstrate the safety of CSTI-500 10mg?

"Limited efficacy and safety data means CSTI-500 10mg only receives a score of 1 on Power's scale. This is because the drug is currently in Phase 1 trials."

Answered by AI

Does this investigation permit octogenarians to participate?

"This trial is available to patients between 13 and 50 years of age. Evidently, there are more clinical trials for individuals over 65 (984) than those under 18 (376)."

Answered by AI

How many participants are being included in this experiment?

"Affirmative. According to clinicaltrials.gov, this research study is currently in the process of enlisting participants. Having been posted on November 14th 2022 and most recently edited on the same date, only 14 volunteers are needed from a single medical site."

Answered by AI

To which patient demographic does enrollment in this trial apply?

"This medical experiment requires 14 people living with Royer Syndrome, aged between 13 and 50. Eligibility is contingent on the following qualifiers: male or female subjects (13-50 years of age at screening); those who have had PWS medically confirmed via genetic testing; no pregnancy or lactation in females, necessitating dual barrier contraception throughout participation; a normal supine systolic pressure ≤140mmHg & ≥100 mmHg and diastolic pressure ≤80mmHg & ≥60 mmHg measured during screening; pulse rate must be within acceptable range, i.e., ≥50bpm to ≤100"

Answered by AI

Are there openings remaining for prospective participants in this experiment?

"Affirmative. According to records available on clinicaltrials.gov, this experiment is presently looking for 14 willing participants from 1 centre. The trial was initially published on November 14th 2022 and has since been updated according to the same date."

Answered by AI
~4 spots leftby Apr 2025