Treatment of Refractory Infantile Spasms With Fenfluramine
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|ClinicalTrials.gov Identifier: NCT04289467|
Recruitment Status : Unknown
Verified February 2020 by Shaun Hussain, MD, University of California, Los Angeles.
Recruitment status was: Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Infantile Spasm||Drug: Fenfluramine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Fenfluramine treatment
Open label treatment with fenfluramine. Dosage will be titrated to 0.8 mg/kg/day, for an initial duration of 21 days. Patients with favorable response will have an option to continue treatment for up to 6 months.
Other Name: Fenfluramine Hydrochloride
- Electroclinical response (Efficacy) [ Time Frame: 12 months ]Number of participants with resolution of epileptic spasms and hypsarrhythmia (if present at baseline) after 21 days of treatment, as determined by overnight video-electroencephalography (EEG) evaluation and caregiver seizure diary.
- Computational electroencephalography response (Efficacy) [ Time Frame: 12 months ]Median and range of response quantified using the probability-weighted response index (PWRI), a novel computational electroencephalography measure of hypsarrhythmia burden.
- Incidence of treatment emergent adverse events (Safety and tolerability) [ Time Frame: 12 months ]Detailed accounting of all treatment-emergent adverse events, including number of participants with clinically-significant valvulopathy and/or pulmonary hypertension, as determined by echocardiography.
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): NCT04289467
|Contact: Angela Martinezemail@example.com|
|Contact: Shaun Hussain, MD||310-206-4037|
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095-1752|
|Principal Investigator:||Shaun Hussain, MD||Univeristy of California, Los Angeles|