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Trial record 20 of 56 for:    insys

Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome

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ClinicalTrials.gov Identifier: NCT02318563
Recruitment Status : Withdrawn (Sponsor elected not to continue with study.)
First Posted : December 17, 2014
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Brief Summary:

This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components (FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and meet the other inclusion/exclusion criteria.

Following a 28-day baseline period, participants will begin an 84-day treatment period. Participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial.

Following study completion, all participants will be invited to receive Cannabidiol Oral Solution in an open label extension study (under a separate protocol).


Condition or disease Intervention/treatment Phase
Dravet Syndrome Drug: Cannabidiol Oral Solution Drug: Placebo Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo- Controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Dravet Syndrome
Estimated Study Start Date : December 30, 2017
Estimated Primary Completion Date : June 17, 2018
Estimated Study Completion Date : June 17, 2018


Arm Intervention/treatment
Experimental: Cannabidiol Oral Solution
Participants will receive cannabidiol oral solution at an appropriate dose (no higher than 40 mg/kg/day) determined by data from a previous trial. The total daily dose will be administered in twice daily doses, approximately 12 hours apart.
Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based)

Placebo Comparator: Placebo Solution
Participants will receive matching placebo solution administered twice daily, approximately 12 hours apart.
Drug: Placebo Solution
A matching oral solution containing no cannabidiol




Primary Outcome Measures :
  1. Percent change in the frequency of tonic-clonic, clonic, and focal seizures with motor components [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]

Secondary Outcome Measures :
  1. Percent change from baseline in the severity of tonic-clonic, clonic, and focal seizures with motor components [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  2. Percent change from baseline in the duration of tonic-clonic, clonic, and focal seizures with motor components [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  3. Percent change from baseline in the frequency of all seizure activity independent of seizure type [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  4. Change from baseline in parent(s)/caregiver(s) Clinical Global Impressions of Improvement (CGI-I) [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  5. Change from baseline in parent(s)/caregiver(s) Clinical Global Impressions of Severity (CGI-S) [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  6. Change from baseline in Investigator CGI-I [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  7. Change from baseline in Investigator CGI-S [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]


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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets protocol-specified criteria for qualification and contraception, including clinical diagnosis of refractory DS and onset of seizures according to protocol-specified criteria
  • Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
  • In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to keep accurate seizure diaries and the participant is able to take study drug and comply with the protocol, including dosing, medications and diet

Exclusion Criteria:

  • Medical history is outside protocol-specified parameters
  • Clinically significant history of allergic reactions or significant sensitivities to cannabinoids or to any of the other ingredients in the study drug
  • Inadequate supervision by parents or guardians
  • 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: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Information from the National Library of Medicine

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): NCT02318563


Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Neha Parikh INSYS Therapeutics Inc

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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02318563     History of Changes
Other Study ID Numbers: INS011-14-025
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by INSYS Therapeutics Inc:
Treatment-resistant seizures

Additional relevant MeSH terms:
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Syndrome
Epilepsies, Myoclonic
Spasms, Infantile
Rett Syndrome
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Pharmaceutical Solutions
Epidiolex
Anticonvulsants