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COMPLETED Phase 1

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

NCT02324673 · View on ClinicalTrials.gov ↗

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

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

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02324673

The ClinicalTrials.gov registry entry for NCT02324673 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02324673 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02324673?

The interventions under investigation include: Cannabidiol Oral Solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02324673?

This trial is sponsored by INSYS Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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