Treatment of Refractory Infantile Spasms With Fenfluramine

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Brief Title

Treatment of Refractory Infantile Spasms With Fenfluramine

Official Title

A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms

Brief Summary

      This is a phase II clinical trial in which children with refractory infantile spasms (also
      called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate
      efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to
      treatment with vigabatrin and ACTH we will be invited to participate. Study participants will
      undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo
      repeat video-EEG to determine effectiveness. Patients with favorable response will have the
      opportunity to continue treatment for up to 6 months.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Electroclinical response (Efficacy)

Secondary Outcome

 Computational electroencephalography response (Efficacy)

Condition

Infantile Spasm

Intervention

Fenfluramine

Study Arms / Comparison Groups

 Fenfluramine treatment
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

April 1, 2020

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Children ages 3 to 36 months, inclusive

          -  Clinical diagnosis of infantile spasms

          -  Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.

        Exclusion Criteria:

          -  Significant preexisting cardiovascular disease

          -  Exposure to any cannabinoid product within 14 days of screening

          -  Initiation or dose-titration of any second-line treatment for infantile spasms in the
             14 days prior to screening.

          -  Implantation of a vagal nerve simulator within 14 days of screening

          -  Initiation and maintenance of the ketogenic diet within 3 months of screening
      

Gender

All

Ages

3 Months - 36 Months

Accepts Healthy Volunteers

No

Contacts

Shaun Hussain, MD, 310-206-4037, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04289467

Organization ID

ZX008-IS


Responsible Party

Principal Investigator

Study Sponsor

University of California, Los Angeles


Study Sponsor

Shaun Hussain, MD, Principal Investigator, Univeristy of California, Los Angeles


Verification Date

February 2020