NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2041200095

Registered date:29/01/2021

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedDravet syndrome
Date of first enrollment18/11/2019
Target sample size390
Countries of recruitmentAustralia,Japan,Belgium,Japan,Canda,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Korea,Japan,Netherland,Japan,Norway,Japan,Spain,Japan,Sweeded,Japan,UK,Japan,US,Japan
Study typeInterventional
Intervention(s)ZX008 (Fenfluramine Hydrochloride) Oral Solution Initial dose: 0.2mg/kg, Max daily dose: 30mg

Outcome(s)

Primary OutcomeLong-term safety and tolerability as measured by treatment emergent adverse events, including clinical labs, vital signs, and examination findings.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 2age old
Age maximum<= 35age old
GenderBoth
Include criteria- Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day of the core study Screening Visit. - Satisfactory completion of the core study in the opinion of the investigator and the sponsor. - A documented medical history to support a clinical diagnosis of Dravet syndrome, where convulsive seizures are not completely controlled by current antiepileptic drugs. - Parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability. - Subject's parent/caregiver has been compliant with diary completion during the core study, in the opinion of the investigator (eg, at least 90% compliant).
Exclude criteria- Current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke. - Current or past history of glaucoma. - Moderate or severe hepatic impairment. - Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates. - Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days, as maintenance therapy. - A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness at Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

Related Information

Contact

Public contact
Name Hideichiro YAMAMOTO
Address 10F Umeda Daibiru, 3-3-10, Umeda, Kita-ku, Osaka Osaka Japan 530-0001
Telephone +81-6-7638-6683
E-mail hideichiro.yamamoto@syneoshealth.com
Affiliation Syneos Health Clinical K.K.
Scientific contact
Name Hideichiro YAMAMOTO
Address 10F Umeda Daibiru, 3-3-10, Umeda, Kita-ku, Osaka Osaka Japan 530-0001
Telephone +81-6-7638-6683
E-mail hideichiro.yamamoto@syneoshealth.com
Affiliation Syneos Health Clinical K.K.