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Trial record 24 of 59933 for:    Placebo

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

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ClinicalTrials.gov Identifier: NCT03355209
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. )

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE November 27, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
Part 1: Change from baseline in frequency of seizures that result in drops in subjects receiving ZX008 compared to placebo [ Time Frame: Up to 20 weeks maintenance and taper period (T+M) ]
Parent/caregiver seizure diary record will be used to assess frequency, type and duration of seizure activity
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Part 1: Change from baseline in frequency of seizures that result in drops in subjects receiving ZX008 compared to placebo. [ Time Frame: Up to 20 weeks maintenance and taper period (T+M) ]
Parent/caregiver seizure diary record will be used to assess frequency, type and duration of seizure activity
Change History Complete list of historical versions of study NCT03355209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
Part 2: Adverse events and related safety parameters in subjects receiving ZX008 compared to placebo [ Time Frame: Up to 12 months open label ]
Safety and tolerability evaluated by reported adverse events, laboratory parameters, physical and neurological examination, vital signs, electrocardiograms, echocardiograms, and body weight
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Part 2: Long-term safety and tolerability [ Time Frame: Up to 12 months open label ]
Parent/caregiver seizure diary record will be used to assess frequency, type and duration of seizure activity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
Official Title  ICMJE A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS
Brief Summary This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Part 1: Double-Blind ZX008 - (0.2 mg/kg/day or 0.8mg/kg/day) or Placebo and Part 2: Open-Label
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part 1: Double-Blind Part 2: Open-Label
Primary Purpose: Treatment
Condition  ICMJE Lennox Gastaut Syndrome
Intervention  ICMJE
  • Drug: ZX008 0.2 or 0.8 mg/kg/day
    ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.
  • Drug: Matching Placebo
    Placebo will be administered twice a day (BID) in equally divided doses.
    Other Name: Placebo Comparator
Study Arms  ICMJE
  • Experimental: ZX008 0.2 or 0.8 mg/kg/day
    Part 1: ZX008 is supplied as an oral solution. Subjects will be randomized to receive 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day) or placebo.
    Intervention: Drug: ZX008 0.2 or 0.8 mg/kg/day
  • Placebo Comparator: Matching Placebo
    Part 1: Matching ZX008 placebo is supplied as an oral solution.
    Intervention: Drug: Matching Placebo
  • Placebo Comparator: Open-Label
    Part 2: ZX008 is supplied as an oral solution. Study medication will be administered twice a day (BID) in equally divided doses.
    Intervention: Drug: ZX008 0.2 or 0.8 mg/kg/day
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit.
  • Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments.
  • Onset of seizures at 11 years of age or younger.
  • Abnormal cognitive development.
  • Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments.

Key Exclusion Criteria:

  • Etiology of seizures is a degenerative neurological disease.
  • History of hemiclonic seizures in the first year of life.
  • Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably.
  • Pulmonary arterial hypertension.
  • Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
  • 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.
  • Taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit.
  • Currently receiving an investigational product.
  • Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care).
  • A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ZX008 Clinical Trials Information Desk 510-388-9968 ClinStudyInfo@zogenix.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Mexico,   Netherlands,   Poland,   Spain,   Sweden,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT03355209
Other Study ID Numbers  ICMJE ZX008-1601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. )
Study Sponsor  ICMJE Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zogenix, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP