Status:
RECRUITING
The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
Lead Sponsor:
Bazelet Nehushtan LtD.
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
ADHD is the most frequent neurodevelopmental disorder in childhood. Symptoms often appear in preschool years, and most children (65-80%) continue to experience some ADHD-associated symptoms into adole...
Detailed Description
Screening phase: Parents who are interested to take part in study, will contact the study team. Parents will be asked to provide documents attesting their child's medical status and forms required to...
Eligibility Criteria
Inclusion
- Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.
- Willing/able to arrive to all the necessary visits as per study protocol.
Exclusion
- Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.
- Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere with the study as per PI opinion.
- Participants suffering from neurological or psychiatric diseases.
- Participants suffering from neoplastic diseases.
- Participants with syndromes or metabolic diseases.
- Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion.
- Pregnant or breastfeeding adolescents.
- Sexually active female adolescents who are unwilling to use contraceptives.
- Participants that in the PI opinion will not comply with the protocol in a way that will harm the study (for ex.: not using contraceptives.)
- Participants with less than 18 kg or more than 90 kg weight.
- Participants with BMI lower than 18 or higher than 29.9.
- Participants engaged in another clinical study which includes a medicine.
- Participants engaged in another study regarding ADHD treatment of any kind.
- Participants using alcohol or drugs.
- Past or present use of Cannabis, including medical cannabis
- Criteria for early termination:
- Use of another medication for ADHD during the study.
- Use of a medication from the exclusion criteria list during the study.
- Use of alcohol or drugs during the study.
- Participants who got pregnant during the study.
- Participants who split the first visit and did not arrive to the second part of the first visit after a maximum of 28 days.
- Participants who did not start the treatment during the 14 days from receiving the drug.
- Non -compliant participants.
- Criteria for exchange:
- PI may exchange participants that quit, if they did not start treatment for new participants.
- PI may recruit again participants who quit after a new full recruitment process.
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 22 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06542445
Start Date
August 22 2024
End Date
September 22 2026
Last Update
August 23 2024
Active Locations (1)
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1
Shamir Medical Center
Ẕerifin, Israel