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Trial record 24 of 59163 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 : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. )

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).

Condition or disease Intervention/treatment Phase
Lennox Gastaut Syndrome Drug: ZX008 0.2 or 0.8 mg/kg/day Drug: Matching Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
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
Official Title: 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
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
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.
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.

Placebo Comparator: Matching Placebo
Part 1: Matching ZX008 placebo is supplied as an oral solution.
Drug: Matching Placebo
Placebo will be administered twice a day (BID) in equally divided doses.
Other Name: Placebo Comparator

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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   2 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355209


Contacts
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Contact: ZX008 Clinical Trials Disclosure Desk 510-388-9968 ClinStudyInfo@zogenix.com

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Locations
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United States, Arizona
Center for Neurosciences Active, not recruiting
Tucson, Arizona, United States, 85718
United States, California
University of California Los Angeles Active, not recruiting
Los Angeles, California, United States, 90095
University of California San Francisco Active, not recruiting
San Francisco, California, United States, 94143
United States, Colorado
The Children's Hospital Colorado Active, not recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Childrens National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
NW FL Clinical Research Group, LLC Active, not recruiting
Gulf Breeze, Florida, United States, 32561
Nicklaus Children's Hospital Active, not recruiting
Miami, Florida, United States, 33155
Florida Hospital Orlando Active, not recruiting
Orlando, Florida, United States, 32803
Pediatric Neurology, PA Active, not recruiting
Orlando, Florida, United States, 32819
United States, Georgia
Clinical Integrative Research Center of Atlanta, Panda Neurology Active, not recruiting
Atlanta, Georgia, United States, 30328
United States, Illinois
Ann & Robert Lurie Children's Hospital of Chicago Completed
Chicago, Illinois, United States, 80045
United States, Maryland
Mid-Atlantic Epilepsy and Sleep Center Active, not recruiting
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Massachusetts General Hospital For Children Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Spectrum Health Completed
Grand Rapids, Michigan, United States, 49503
William Beaumont Hospital Active, not recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
Minnesota Epilepsy Group, PA Active, not recruiting
Saint Paul, Minnesota, United States, 55102
United States, New Jersey
Northeast Regional Epilepsy Group Active, not recruiting
Hackensack, New Jersey, United States, 07601
Institute of Neurology and Neurosurgery at St. Barnabas Active, not recruiting
Livingston, New Jersey, United States, 07039
United States, New York
Icahn School of Medicine at Mount Sinai Active, not recruiting
Hartsdale, New York, United States, 10530
NYU Comprehensive Epilepsy Center Active, not recruiting
New York, New York, United States, 10016
United States, Ohio
University Hospital Cleveland Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Wellspan Pediatric Neurology Active, not recruiting
Manchester, Pennsylvania, United States, 17345
Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104-4318
United States, Texas
UT Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75235
Cook's Children's Medical Center Active, not recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Active, not recruiting
San Antonio, Texas, United States, 78207
United States, Utah
University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84108
United States, Washington
MultiCare Institute for Research & Innovation Active, not recruiting
Tacoma, Washington, United States, 98405
Australia
Melbourne Brain Centre Austin Hospital Active, not recruiting
Heidelberg, Australia, 3084
Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital Active, not recruiting
South Brisbane, Australia, QLD 4101
Belgium
Universitair Ziekenhuis Antwerpen Active, not recruiting
Antwerpen, Belgium, 2650
Hôpital Universitaire Des Enfants Reine Fabiola Active, not recruiting
Brussels, Belgium, 1020
Universitair Ziekenhuis Brussel Active, not recruiting
Brussels, Belgium, 1090
Canada, British Columbia
British Columbia Children's Hospital Active, not recruiting
Vancouver, British Columbia, Canada, 6H 3N1
Canada, Ontario
Sick Kids Active, not recruiting
Toronto, Ontario, Canada, M5G1X8
Denmark
Epilepsihospitalet Filadelfia Active, not recruiting
Dianalund, Denmark, DK4293
France
Hôpital des enfants- Pellegrin- CIC Pédiatrique Active, not recruiting
Bordeaux, France, 33076
Hôpital Femme Mère Enfant Active, not recruiting
Bron, France, 69677
CHRU Lille Hopital Roger Salengro Neurophysiologie Clinique (RDC) Active, not recruiting
Lille, France, 59037
AP-HM - CHU TIMONE ENFANTS Service de Neurologie Pédiatrique Active, not recruiting
Marseille, France, 13385
Hôpital Universitaire Necker-Enfants Malades Service de neurologie pédiatrique Active, not recruiting
Paris, France, 75015
Hôpital Robert Debré Pédiatrie Médicale Service Neurologie Et Maladies Métaboliques Robert-debré Active, not recruiting
Paris, France, 75019
Germany
Krankenhaus Mara GmbH Active, not recruiting
Bielefeld, Germany, 33617
Italy
AOU Anna Meyer Clinica di Neurologia Pediatrica Active, not recruiting
Firenze, Italy, 50139
Istituto Pediatrico Giannina Gaslini Active, not recruiting
Genova, Italy, 16148
Ospedale Bambino Gesù, IRCS Active, not recruiting
Roma, Italy, 00165
Unita Operativa di Neuropsichiatria Infantile, Universita Cattolica del Sacro Cuore, Fondazione Poli Active, not recruiting
Roma, Italy, 00168
Japan
NHO Nagaski Medical Center Recruiting
Omura, Nagasaki, Japan
NHO Nishi-Niigata Chuo National Hospital Recruiting
Niigata-shi, Niigata, Japan
Okayama University Hospital Recruiting
Okayama-shi, Okayama, Japan
Saitama Children's Medical Center Not yet recruiting
Saitama-shi, Saitama, Japan
National Epilepsy Center Shizuoka Recruiting
Shizuoka-city, Shizuoka, Japan
Tokyo Women's Medical University Hospital Not yet recruiting
Shinjuku-ku, Tokyo, Japan
Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde Active, not recruiting
Jalisco, Guadalajara, Mexico, 44280
Netherlands
Epilepsy center SEIN - Zwolle Active, not recruiting
Zwolle, Netherlands, 8025BV
Poland
NZOZ Vitamed Active, not recruiting
Bydgoszcz, Poland, 85-079
Centrum Medyczne Plejady Active, not recruiting
Kraków, Poland, 30-363
Spain
Hospital del Mar Active, not recruiting
Barcelona, Spain, 08022
Hospital Ruber Internacional Servicio de Neurologia Active, not recruiting
Madrid, Spain, 28034
Clinica Universitaria de Navarra Active, not recruiting
Pamplona, Spain, 31008
Sponsors and Collaborators
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

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Responsible Party: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT03355209     History of Changes
Other Study ID Numbers: ZX008-1601
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. ):
LGS

Additional relevant MeSH terms:
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Syndrome
Lennox Gastaut Syndrome
Disease
Pathologic Processes
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Pharmaceutical Solutions
Fenfluramine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs