Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder

Completed · Phase 3

Conditions studied: Seizures

In brief

This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673) and INS011-15-054 (NCT02551731).

Key facts

Study ID

NCT02318602

Run by

INSYS Therapeutics Inc

People needed

52

Starts

2016-01-08

Expected to finish

2017-06-22

Last updated by the study team

2018-07-26

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054
• Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
• Is medically stable with no anticipated changes in chronic medications in the opinion of the Investigator
• Continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
• In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries

You may not qualify if…

• Inadequate supervision by parent(s)/caregiver(s)
• History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
• Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
• the safety or well-being of the participant or study staff
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
• the analysis of results

Where it is running

• University of California San Francisco Medical Center — San Francisco, California, United States
• Miami Children's Hospital — Miami, Florida, United States
• Child Neurology Center - NW F — Pensacola, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Clinical Research Center of Nevada LLC — Las Vegas, Nevada, United States
• Oregon Health Services University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Texas Scottish Rite Hospital for Children — Dallas, Texas, United States
• Granger Medical Clinic — Riverton, Utah, United States
• Mary Bridge Children's Hospital — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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