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A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome

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ClinicalTrials.gov Identifier: NCT03458416
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 8, 2018
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE September 6, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Associated with Cannabidiol Oral Solution [ Time Frame: Baseline (Visit 10 of INS011-16-085) up to Visit 9 (approximately Week 52) ]
  • Number of Participants with Change from Baseline in Vital Signs [ Time Frame: Baseline (Visit 10 of INS011-16-085) up to Visit 7 (approximately Week 48) ]
  • Number of Participants with Change from Baseline in Physical Exam [ Time Frame: Baseline (Visit 10 of INS011-16-085) up to Visit 7 (approximately Week 48) ]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Baseline (Visit 10 of INS011-16-085) up to Visit 7 (approximately Week 48) ]
  • Number of Participants with Change from Baseline in Laboratory Values [ Time Frame: Baseline (Visit 10 of INS011-16-085) up to Visit 7 (approximately Week 48) ]
  • Number of Participants with Change from Baseline in Weight [ Time Frame: Baseline (Visit 10 of INS011-16-085) up to Visit 7 (approximately Week 48) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03458416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome
Official Title  ICMJE A Multicenter, Open-Label Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome
Brief Summary The objective of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in patients with Prader-Willi Syndrome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prader-Willi Syndrome
Intervention  ICMJE Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Study Arms  ICMJE Experimental: Cannabidiol Oral Solution: 20-40 mg/kg/day
Participants will receive total daily doses between 20 milligrams per kilograms per day (mg/kg/day), 30 mg/kg/day, and 40 mg/kg/day. The two equivalent doses will be administered twice a day with a standard meal approximately every 12 hours.
Intervention: Drug: Cannabidiol Oral Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Completed activities up to and including Visit 10 (Study Completion) of INS011-16- 085.
  2. Patient and/or parent(s)/caregiver(s) fully comprehend the informed consent form (ICF) and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
  3. If female, is either not of childbearing potential or practicing medically acceptable methods of birth control.
  4. Psychotropic treatment will be permitted if the subject has been on a stable dose during the INS011-16-085 and does not anticipate a dose change during the course of the study.
  5. Growth hormone treatment will be permitted if the subject has been on a stable dose during INS01-16-085.
  6. Any other treatment including thyroid hormones should be stable prior to entering the INS011-17-115 study.
  7. In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and able to comply with the study procedures and visit schedules, including venipuncture, and the visit schedules.

Exclusion Criteria:

  1. Patient or parent(s)/caregiver(s) have commitments during the study duration that would interfere with attending all study visits.
  2. Experienced an anoxic episode related to study drug requiring resuscitation during the previous study.
  3. Uncontrolled Type I and Type II Diabetes.
  4. Developed an adverse event thought to be related to CBD in the previous study and the investigator determines that continuing treatment with CBD would not be in the best interest of the patient.
  5. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or other condition which would jeopardize safety or impact validity of results (per investigator).
  6. Currently taking felbamate.
  7. Compromised respiratory function or severe respiratory insufficiency.
  8. Pregnant or lactating female..
  9. In the opinion of the investigator, the patient is unsuitable in any other way to participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03458416
Other Study ID Numbers  ICMJE INS011-17-115
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INSYS Therapeutics Inc
Study Sponsor  ICMJE INSYS Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ahmed Elkashef, MD INSYS Therapeutics Inc
PRS Account INSYS Therapeutics Inc
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP