. 2022 Apr 20;63(7):1736–1747. doi: 10.1111/epi.17247

TABLE 1.

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Female	Comorbid significant neurological diagnosis (e.g., traumatic brain injury, metabolic condition, CNS infection)
≥6 years old	Comorbid significant nonneurological diagnosis (e.g., severe cardiac or respiratory disease)
≥10 kg	Significant abnormality of baseline blood tests ^a , ^b
Confirmed disease causing mutation in MECP2 gene ^c	Clinically significant ECG abnormality ^b , ^d
Drug resistant epilepsy defined: 1. Failed adequate trial of at least two standard anticonvulsants ^e 2. At least four quantifiable seizures ^f 8 weeks prior to screening AND at least two quantifiable seizures in the baseline period	Current or previous use of recreational or medicinal cannabis, or cannabinoid‐based medication within 3 months
	Pregnant
	Known allergy to CBDV component or any cannabinoid
Patient and guardian able to comply with trial requirements	Other significant disease or disorder that might put patient at risk, or influence trial results or patient’s ability to comply
All medications and interventions for Rett syndrome‐related symptoms stable 4 weeks prior to screening	Abnormal physical examination that would impact safety of patient undertaking trial
	Concomitant use of more than four anticonvulsant medications
	Felbamate use in the prior 12 months ^g

Abbreviations: CBDV, cannabidivarin; CNS, central nervous system; ECG, electrocardiogram.

^{^a}

Complete blood picture (white blood cell count < 4.0 x 10⁹/L, platelets < 60 000, absolute neutrophil count < 1.0 x 10⁹/L), electrolytes, hepatic function, or enzymes (alanine aminotransferase or aspartate aminotransferase > 2 × upper limit normal).

^{^b}

As assessed by investigator.

^{^c}

Assessed by neurologist or medical geneticist.

^{^d}

Corrected QT interval > 460 ms, PR interval > 0.2 s, QRS duration > 0.1 s.

^{^e}

Assessed by the investigator/treating clinician.

^{^f}

Easily counted by parents: generalized tonic–clonic, drop attacks, focal seizure with impaired awareness. Excludes simple staring and myoclonus.

^{^g}

Due to high risk of side effects and difficulty establishing whether adverse events are secondary to CBDV or felbamate introduction.