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Serotonin Receptor Agonist

Fenfluramine Hydrochloride for Childhood Disintegrative Disorder

Phase 2

Waitlist Available

Led By Orrin Devinsky, MD

Research Sponsored by NYU Langone Health

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 baseline, week 14

Awards & highlights

Study Summary

This trial will be testing fenfluramine for seizure control in children and adolescents with CDKL5 Deficiency Disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Median Monthly Convulsive Seizure Frequency

Secondary outcome measures

Change in Caregiver Global Impression of Change (CGIC) Score

Change in Investigator Global Impression of Change (IGIC) Score

Change in Pediatric Quality Of Life (PEDS-QL) Epilepsy Module Raw Score

+1 more

Side effects data

From 2022 Phase 2 trial • 7 Patients • NCT03861871

86%

Lethargy

86%

Low appetite

43%

Upper respiratory infection

43%

Common cold

29%

Weight Loss

29%

Diarrhea

29%

Crying episode

29%

Constipation

14%

Teething

14%

Urinary tract infection

14%

Hair loss

14%

Vomitting

14%

Low grade fever

14%

Screaming episode

14%

Pneumonia

14%

Intestinal gas

14%

Rash on face

14%

Loose bowel

14%

Bite on finger

14%

Aspiration pneumonia

14%

Irritability

14%

Respiratory infection

14%

Low tone

14%

Loose stool

14%

Mucus plug in throat

14%

Sialorrhea

14%

Regurgitation after meals

14%

Grinding teeth

14%

SARS-CoV2 infection

14%

Clostridium dificile infection

100%

80%

60%

40%

20%

Study treatment Arm

Fenfluramine Hydrochloride

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fenfluramine HydrochlorideExperimental Treatment1 Intervention

Study medication will be administered as equal doses twice a day in the morning and in the evening approximately 12 hours apart. Patients will first be titrated over 14 days to a dose of ZX008 0.8 mg/kg/day (maximum dose 30 mg/d). After completion of the Titration Period, patients will continue to receive the ZX008 0.8 mg/kg/day dose and be treated for an additional 12 weeks (Maintenance Period). Study medication will continue to be administered twice a day in the morning and in the evening, approximately 12 hours apart. After completion of the Maintenance Period, patients will enter the Taper Period, where they will decrease from 0.8 mg/kg twice a day to a dose of 0.4 mg/kg twice a day (maximum 30 mg/day). After 4 days at this dose level, patients will decrease their dose to 0.2 mg/kg/day. On day 9 of the Taper Period, all participants will stop taking study medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fenfluramine Hydrochloride

2019

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,719 Total Patients Enrolled

Orrin Devinsky, MDPrincipal InvestigatorNYU Langone Health

5 Previous Clinical Trials

2,149 Total Patients Enrolled

Frequently Asked Questions

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

Are there any restrictions on who is able to join this clinical trial?

"This trial is looking for 10 participants that have cdd and meet the following age criteria: between 2 and 18 years old. Additionally, candidates should be male or non-pregnant/non-lactating females who are not of childbearing potential. Those of childbearing potential must use birth control for the duration of the study +30 days after their last dose of medication. All subjects must be able to provide assent, have a compliant caregiver, and be receiving stable doses of anti-seizure medication or vagus nerve stimulation therapy. Lastly, during the 4 weeks prior to screening and throughout the study, participants must"

Answered by AI

Are there any open spots for new participants in this research?

"Enrolment for this trial is currently closed. The study was originally advertised on October 29th, 2019 with the latest update being from April 5th, 2022. If you are interested in other studies, there 1 active clinical trials searching for participants with cdd and 6 Fenfluramine Hydrochloride trials also recruiting."

Answered by AI

Is Fenfluramine Hydrochloride more likely to cause harm or help people?

"Fenfluramine Hydrochloride is currently in Phase 2 of clinical trials. While there is some evidence supporting its safety, more data needs to be collected to confirm its efficacy."

Answered by AI

How many people are enrolled in this experiment?

"Unfortunately, this particular trial is not actively recruiting patients right now. However, the study was last edited on April 5th, 2022 and there are other trials involving Fenfluramine Hydrochloride that are still looking for participants."

Answered by AI

Is this an original research project?

"Fenfluramine Hydrochloride has been studied since 2016, with the first trial sponsored by Zogenix International Limited, Inc.. The trial involved 373 patients. Following the success of the Phase 1 study, Fenfluramine Hydrochloride was approved for Phase 3 trials. To date, there are 6 active clinical trials across 56 cities and 15 countries."

Answered by AI

Does this experimental treatment extend to people below a certain age bracket?

"As 2 is the youngest age allowed and 18 the eldest, this clinical trial abides by the inclusion criteria with regards to age."

Answered by AI

Are there other similar medical studies that have used Fenfluramine Hydrochloride?

"There are currently 6 ongoing clinical trials researching Fenfluramine Hydrochloride. Of these, 5 have progressed to Phase 3. Many of the trials for this medication are based in Boston, however there are 236 total locations running these tests across the United States."

Answered by AI

Recent research and studies

EpilepsiaJournal

Effect of Fenfluramine on Convulsive Seizures in CDKL5 Deficiency Disorder

Devinsky, Orrin, LaToya King, Danielle Schwartz, Erin Conway, and Dana Price. 2021. “Effect of Fenfluramine on Convulsive Seizures in CDKL5 Deficiency Disorder”. Epilepsia. Wiley. doi:10.1111/epi.16923.

clinicaltrials.govStudy

Fenfluramine in CDKL5 Deficiency Disorder (CDD)

2019. "Fenfluramine in CDKL5 Deficiency Disorder (CDD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03861871.