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ZX008 (Fenfluramine Hydrochloride) for CDKL5 Deficiency Disorder

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
CDKL5 Deficiency Disorder+3 MoreZX008 (Fenfluramine Hydrochloride) - Drug
Eligibility
1 - 35
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if ZX008 is an effective and safe adjunctive therapy for people with uncontrolled seizures due to CDKL5 deficiency disorder.

Eligible Conditions
  • CDKL5 Deficiency Disorder
  • Refractory Seizures
  • Grand Mal Seizure
  • Epileptic Spasm

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
NBI-921352
2
XEN496
2
XEN496

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 14 Weeks

14 Weeks
The median percentage change from Baseline in monthly Generalized Tonic-Clonic (GTC) seizure frequency
The median percentage change from the Baseline Period (Baseline) in "monthly (28 days) countable motor seizure frequency
The percentage of subjects who achieve a ≥ 50% reduction from Baseline in CMSF
The percentage of subjects who achieve improvement in the Clinical Global Impression-Improvement (CGI-I) rating as assessed by the Investigator

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
NBI-921352
3
XEN496
3
XEN496

Side Effects for

Study 3: ZX008 0.8 mg/kg/Day
38%Decreased appetite
21%Somnolence
19%Pyrexia
17%Blood glucose decreased
17%Echocardiogram abnormal
15%Diarrhoea
13%Tremor
10%Fatigue
8%Platelet count decreased
8%Upper respiratory tract infection
8%Weight decreased
8%Rash
6%Lethargy
6%Asthenia
6%Cough
6%Vomiting
6%Hypoglycaemia
4%Abnormal behaviour
4%Rhinitis
4%Blood pressure increased
4%Viral infection
4%Ataxia
4%Drooling
4%Balance disorder
2%Urinary tract infection
2%Hypotonia
2%Seizure
2%Rhinorrhoea
2%Varicella
2%Hepatic enzyme increased
2%Toxicity to various agents
2%Nasopharyngitis
2%Constipation
2%Sinusitis
2%Blood pressure diastolic increased
2%Influenza
2%Irritability
2%Urinary incontinence
2%Gait disturbance
2%Fall
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02682927) in the Study 3: ZX008 0.8 mg/kg/Day ARM group. Side effects include: Decreased appetite with 38%, Somnolence with 21%, Pyrexia with 19%, Blood glucose decreased with 17%, Echocardiogram abnormal with 17%.

Trial Design

3 Treatment Groups

ZX008
1 of 3
ZX008 0.8 mg/kg/day
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

100 Total Participants · 3 Treatment Groups

Primary Treatment: ZX008 (Fenfluramine Hydrochloride) · Has Placebo Group · Phase 3

ZX008
Drug
Experimental Group · 1 Intervention: ZX008 (Fenfluramine Hydrochloride) · Intervention Types: Drug
ZX008 0.8 mg/kg/day
Drug
Experimental Group · 1 Intervention: ZX008 (Fenfluramine Hydrochloride) · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Matching ZX008 Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenfluramine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14 weeks

Who is running the clinical trial?

Zogenix, Inc.Lead Sponsor
24 Previous Clinical Trials
2,473 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
189 Previous Clinical Trials
43,560 Total Patients Enrolled

Eligibility Criteria

Age 1 - 35 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a confirmed pathogenic or likely pathogenic mutation in the CDKL5 gene and a clinical diagnosis of CDD with epilepsy onset in the first year of life, plus motor and developmental delays.
You have ≥ 4 countable motor seizures (CMS) per week.
Subject must have failed to achieve seizure control despite previous or current use of 2 or more AETs.
References

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