Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:3 - 17
Updated:4/5/2019
Start Date:February 20, 2018
End Date:November 2019

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A Multicenter, Open-Label, Flexible Dose Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures

The primary purpose of this study is to assess the long-term safety and tolerability of
Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood
absence seizures.


Inclusion Criteria:

1. Completed all activities through Visit 6 (End of Study) of INS011-17-103.

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. A female patient is eligible to participate in the study if she is premenarchal, or of
childbearing potential with a negative urine pregnancy test at the Screening Visit. If
sexually active, she must agree to either complete abstinence from intercourse or use
acceptable methods of contraception throughout the study and for 4 weeks after
completion of study participation or discontinuation from investigational product.

4. A sexually active male patient or partner of enrolled patient must be willing to use
acceptable methods of contraception throughout the study and for 4 weeks after
completion of study participation or discontinuation from investigational product.

5. 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 daily 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
their previous study.

3. Developed an adverse event thought to be related to CBD in the previous study and for
whom the Investigator determines that continuing treatment with CBD would not be in
the best interest of the patient.

4. Evidence of other clinically significant disease such as unstable hepatic,
hematological, renal, cardiovascular, gastrointestinal, immunological, or pulmonary
diseases or ongoing malignancies.

5. Compromised respiratory function or severe respiratory insufficiency.

6. Clinically significant abnormal laboratory values within the past 14 days.

7. In the opinion of the investigator, the patient is unsuitable in any other way to
participate in this study.
We found this trial at
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Norfolk, Virginia 23510
Phone: 757-668-9356
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Phone: 330-543-0690
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-4136
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-8881
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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5673 Ptree Dun Rd NE # 440
Atlanta, Georgia 30342
Phone: 678-705-7341
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Miami, Florida 33155
Phone: 786-624-3516
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Salt Lake City, Utah 84143
Phone: 801-587-1227
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Tacoma, Washington 98405
Phone: 253-403-9348
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Tampa, Florida 33609
Phone: 813-873-7367
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