Open-label Extension to Protocol 1042-0500

Stopped early · Phase 2

Conditions studied: Infantile Spasms

In brief

To allow open-label extension to patients who have completed Protocol 1042-0500

Key facts

Study ID

NCT00442104

Run by

Marinus Pharmaceuticals

People needed

54

Starts

2007-01-01

Expected to finish

2009-03-01

Last updated by the study team

2024-05-28

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have completed all scheduled clinical study visits in the previous Protocol 1042 0500 and have been deemed eligible (no SAEs thought to be drug related and had a response to treatment) by the Investigator.
• 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.

You may not qualify if…

• Current treatment with more than 2 concomitant AEDs.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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