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NCT02324673 · ClinicalTrials.gov registry record · Phase 1

Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders

A Phase 1 study of Seizures, sponsored by INSYS Therapeutics.

Completed
Registry status
Phase 1
Development phase
61
Enrollment target
10
Study locations

NCT02324673 is a Phase 1 study of Seizures that has completed, run by INSYS Therapeutics. The registered enrollment target is 61 participants, below the 933-participant average among 39 other Seizures trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT02324673, a Phase 1 study of Seizures, has completed, sponsored by INSYS Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
61 participants
Enrollment target
10
Study locations

Study Summary

This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion. Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant seizures, and satisfy all inclusion/exclusion criteria.

Conditions Studied

Seizures

Interventions

  • DRUG Cannabidiol Oral Solution

Study Locations (10)

Florida

  • Miami Children's Hospital - Miami
  • Child Neurology Center - NW F - Pensacola

California

  • University of California San Francisco Medical Center - San Francisco

Illinois

  • University of Chicago Medical Center - Chicago

Nevada

  • Clinical Research Center of Nevada LLC - Las Vegas

Oregon

  • Oregon Health Services University - Portland

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Tennessee

  • Le Bonheur Children's Hospital - Memphis

Texas

  • Texas Scottish Rite Hospital for Children - Dallas

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2015-04-13
Est. Completion 2016-05-09
Phase Phase 1

Sponsor

INSYS Therapeutics

35 total trials

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What the Registry Record Tells You About NCT02324673

The ClinicalTrials.gov registry entry for NCT02324673 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 933-participant average among 39 other Seizures trials with a reported enrollment target (93% lower). The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 1 intervention - of which Cannabidiol Oral Solution is the first listed.

NCT02324673 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT02324673 about?

NCT02324673 is a clinical study titled "Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders". This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion. Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant s...

What is the current status of trial NCT02324673?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2015-04-13. Estimated completion is 2016-05-09.

What conditions does trial NCT02324673 study?

This clinical trial studies the following conditions: Seizures.

What interventions are being tested in trial NCT02324673?

The interventions under investigation include: Cannabidiol Oral Solution (DRUG).

Who is sponsoring clinical trial NCT02324673?

This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02324673 being conducted?

This trial has 10 study locations across California, Florida, Illinois, Nevada, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.