Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2007-01-31
2009-03-31
Brief Summary
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Detailed Description
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There will be a total of 14 visits over 99(+or-1)week. A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ganaxolone
Ganaxolone
Interventions
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Ganaxolone
Eligibility Criteria
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Inclusion Criteria
* Be diagnosed with IS regardless of etiology. Diagnostic Criteria: Seizures consisting of single or repetitive short muscular contractions leading to flexion or extension. Spasms may be characterized as tonic or myoclonic contractions, may occur singly or in clusters, and typically occur bilaterally and symmetrically. The EEG pattern must be consistent with the diagnosis of IS (hypsarrhythmia, modified hypsarrhythmia, multifocal spike wave discharges, etc).
* Have a 24 hour vEEG recording confirming the diagnosis of IS.
* Have had a magnetic resonance imaging (MRI) performed to determine any possible causes of IS.
* Have been previously treated with 3 AEDs or fewer.
* Have a parent/guardian who is properly informed of the nature and potential risks and benefits of the clinical study, is willing and capable of complying with all clinical study procedures, and has given informed consent in writing prior to entering the clinical study.
Exclusion Criteria
* Have an active CNS infection, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive (with the exception of tuberous sclerosis) as evaluated by brain MRI.
* Have any disease or condition (medical or surgical) at Screening that might compromise the hematologic, cardiovascular, pulmonary, renal, GI, or hepatic systems; or other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the investigational product, or would place the subject at increased risk.
* Aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin greater than 4 times the upper limit of laboratory normal or any clinical laboratory value deemed clinically significant by the Investigator.
* History of recurrent status epilepticus.
* Have been exposed to any other investigational drug within 30 days prior to enrollment.
4 Months
24 Months
ALL
No
Sponsors
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Marinus Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Mattel Children's Hospital at UCLA
Los Angeles, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Miami Children's Hospital, The Brain Institute
Miami, Florida, United States
Child Neurology Center of Nrothwest Florida, P.A.
Pensacola, Florida, United States
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States
Minnesota Epilepsy Group, P.A.
Saint Paul, Minnesota, United States
Montefiore Medical Center- Albert Einstein College of Medicine
The Bronx, New York, United States
Le Bonheur Children's Medical Center
Memphis, Tennessee, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Virginia Commonwealth University Health Systems
Richmond, Virginia, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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Amend 5 (ROW)
Identifier Type: -
Identifier Source: secondary_id
Amend 6 (US)
Identifier Type: -
Identifier Source: secondary_id
1042-0501
Identifier Type: -
Identifier Source: org_study_id
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