Health TrialsbyHealthPanel

Effect of CBD on the Brain

ConditionFragile X Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-55
SponsorUniversité de Sherbrooke

About this trial

This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age between 7 and 55 years, molecular diagnosis of FXS,

intelligence quotient (IQ) <70,

aberrant behavior questionnaire score (ABC-C) > 20,

<3 psychoactive drugs, drug stable for > 3 months.

Disqualifiers

The presence of an absolute contraindication to the use of TMS and MRI / MRS (ie presence of metal in the head).

Individuals with ALT / ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline,

Trial design

Design model

Crossover

Treatments tested in this trial

  • CBD Oral Solution (eCBD system Target)

    Drug

    Participants receive orally 6 ml of CBD Oral Solution (100 mg / ml; 60 mg / kg; max 600 mg of CBD) followed by 6 ml of a placebo composed of the inactive ingredients of CBD Oral Solution 3 weeks later.

  • Placebo

    Drug

    Participants receive orally 6 ml of a placebo composed of the inactive ingredients of CBD Oral Solution followed by 6 ml of Oral CBD Solution (100 mg / ml; 60 mg / kg; max 600 mg of CBD)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CBD firstExperimental treatment 2 interventions
Group B: Placebo firstExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Short Intracortical Inhibition

Transcranial Magnetic Stimulation (TMS)-derived measure of Intracortical inhibition: The degree of decrease of peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of a conditioning stimulus (set at 70% of resting motor threshold) 2-4 ms before the test stimulus (stimulation intensity required to produce an MEP of 1 millivolt (mV), approximately 120% of resting motor threshold)

Time frame
Comparison between pre and 2 hours post administration of Oral CBD solution and placebo

Secondary outcomes

1

Intracortical Facilitation

TMS-derived measure of Intracortical Facilitation: The degree of increase of peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of a conditioning stimulus (set at 80% of resting motor threshold) 12-24 ms before the test stimulus (stimulation intensity required to produce an MEP of 1 mV, approximately 120% of resting motor threshold).

Time frame
Comparison between pre and 2 hours post administration of Oral CBD solution and placebo
2

Gaba concentration levels

Estimation of GABA concentrations in the brain from magnetic resonance spectroscopy (MRS)

Time frame
Comparison between pre and 2 hours post administration of Oral CBD solution and placebo

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Jazz Pharmaceuticals

Collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Source ClinicalTrials.gov

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