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Sponsored by: |
Marinus Pharmaceuticals |
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Information provided by: | Marinus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00441896 |
The study is a two period (8-10 days/period), incomplete cross-over in which successive cohorts of 9 subjects are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of 6 subjects, receives ascending doses of ganaxolone during period 1 and ganaxolone (at the maximal dose attained in period 1) and ascending doses of placebo during period 2. Sequence B, comprised of 3 subjects, receives ascending doses of placebo during period 1 and receives the maximum dose of placebo and ascending doses of ganaxolone during period 2. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts.
Condition | Intervention | Phase |
---|---|---|
Infantile Spasms |
Drug: Ganaxolone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Dose-Ranging Clinical Study to Evaluate the Safety, Tolerability, and Antiepileptic Activity of Ganaxolone in Treatment of Patients With Infantile Spasms |
Estimated Enrollment: | 54 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | August 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Male or female, 4 to 24 months of age (inclusive) with a diagnosis of IS with a 24 hour video EEG (vEEG) recording confirming the diagnosis and previously treated with 3 or fewer antiepileptic drugs (AEDs) are eligible for the study. The subject is able to continue treatment with concomitant AEDs (no more than 2; adrenocorticotropic hormone [ACTH], corticosteroids, felbamate, and vigabatrin are not allowed concomitantly). A ketogenic diet is permitted if it can be maintained for the duration of the study.
There will be a total of three weekly 24-hr video EEGs (baseline, end of weeks 1 and 2 of treatment). Dosing titration begins the day after each video EEG during the inpatient stay. All subjects will be receiving ganaxolone the day after the second video EEG.
A Data Monitoring Board (DMB) will determine whether successive cohorts of subjects can be dosed at an increased dose level; up to a maximum of 6 cohorts.
Ages Eligible for Study: | 4 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If being treated with concomitant AEDs
Exclusion Criteria:
United States, California | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
Mattel Children's Hospital at UCLA | |
Los Angeles, California, United States, 90095 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
Miami Children's Hospital, The Brain Institute | |
Miami, Florida, United States, 33155 | |
Child Neurology Care Center of Northwest Florida | |
Pensacola, Florida, United States, 32504 | |
Child Neurology Center of Northwest Florida | |
Pensacola, Florida, United States | |
United States, Illinois | |
University of Chicago Comer Children's Hospital | |
Chicago, Illinois, United States, 60637 | |
United States, Minnesota | |
Minnesota Epilepsy Group, P.A. | |
St. Paul, Minnesota, United States, 55102 | |
United States, New York | |
Montefiore Medical Center- Albert Einstein College of Medicine | |
Bronx, New York, United States, 10467 | |
United States, Tennessee | |
Le Bonheur Children's Medical Center | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
Dallas Pediatric Neurology Associates | |
Dallas, Texas, United States, 75230 | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Commonwealth University Health System | |
Richmond, Virginia, United States, 23298 | |
United States, Washington | |
Children's Hospital and Regional Medical Center | |
Seattle, Washington, United States, 98105 | |
United States, Wisconsin | |
Children's Hospital of Wisconsin | |
Milwaukee, Wisconsin, United States, 53201 |
Study ID Numbers: | 1042-0500 |
Study First Received: | February 27, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00441896 |
Health Authority: | United States: Food and Drug Administration |
infantile spasms anticonvulsant pediatric epilepsy West Syndrome epileptic spasms |
Spasm Signs and Symptoms Spasms, Infantile West syndrome Epilepsy |
Central Nervous System Diseases Neurologic Manifestations Infantile spasms Brain Diseases Epilepsy, Generalized |
Neuromuscular Manifestations Nervous System Diseases |