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Appetite Stimulant
Cyproheptadine for Pediatric Feeding Disorders
Miami, FL
Phase 4
Recruiting
Led By Miguel Saps, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age Range: 2-6 years
Be younger than 18 years old
Must not have
Patients who are tube fed
Patients who are overweight (BMI at 85th%tile or greater)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial aims to see if Cyproheptadine, a medication that increases appetite, can help children with Pediatric Feeding Disorders improve their eating habits. Pediatric Feeding Disorders refer to conditions that
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Who is the study for?
This trial is for children with Pediatric Feeding Disorders, which affect their eating habits and health. It's open to those who struggle with consuming enough food due to various eating-related behaviors.Check my eligibility
What is being tested?
The study tests if Cyproheptadine, an appetite stimulant, can help improve the eating patterns of these children. The trial includes behavioral and nutritional counseling as part of the treatment process.See study design
What are the potential side effects?
Cyproheptadine may cause drowsiness, dry mouth, dizziness, or constipation in some children. Side effects vary from child to child.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 6 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I receive my nutrition through a feeding tube.
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I am overweight according to BMI standards.
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I have active symptoms from a GI disorder like IBD, EoE, or Gastritis.
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I am currently in therapy to improve my eating habits.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Child Food Neophobia score
Change in Children's Eating Behavior Questionnaire score
Number of foods consumed by participants
Secondary study objectives
Change in BMI
Change in BMI Z-score
Change in BMI percentile
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Nutritional Counseling in Combination with Behavioral CounselingExperimental Treatment2 Interventions
Participants in the group will receive nutritional and behavioral counseling for up to 6 months
Group II: CyproheptadineExperimental Treatment3 Interventions
Participants in this group will receive the Cyproheptadine for up to 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional Counseling
2016
Completed Phase 2
~560
Cyproheptadine
2011
Completed Phase 4
~330
Behavioral Counseling
2019
Completed Phase 4
~650
Find a Location
Closest Location:University of Miami Department of Pediatric Gastroenterology· Miami, FL· 1324 miles
Who is running the clinical trial?
University of MiamiLead Sponsor
974 Previous Clinical Trials
423,315 Total Patients Enrolled
Miguel Saps, MDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
126 Total Patients Enrolled