| Eligibility |
Inclusion Criteria:
- Must sign an informed consent form (ICF) indicating that they understand the purpose
of the study and the procedures required for the study; and are willing to participate
in the study and attend all visits and requirements.
- Individuals age 18-65 years, inclusive.
- A history of a photoparoxysmal response on EEG with or without a diagnosis of epilepsy
for which subjects are on 0-3 concomitant antiseizure medications (ASMs).
- At least 3 of the EEGs performed during the Screening Visit must have a reproducible
IPS-induced photoparoxysmal response (PPR) on EEG of =3 points on a frequency
assessment scale in the same eye condition.
- Subjects in otherwise good health (with the exception of epilepsy), as determined by
the PI via the medical history, a physical examination and screening laboratory
investigations.
- A body mass index (BMI) between 17.5 to 42
- Participants agree to refrain from strenuous exercise the day before Screening and
during the day prior to treatment days.
- Females of childbearing potential must commit to the consistent and correct use of an
effective method of birth control throughout the study and must also have negative
pregnancy test results at all visits prior to investigational product (IP)
administration. Effective methods of contraception include surgical sterilization of
the subject, condoms with spermicide, diaphragm with spermicide, hormonal
contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive
devices.
- Negative viral serology test results for hepatitis B and C virus.
- Must have no medical contraindication to CBD, including known allergies or
hypersensitivities to CBD or the excipients in RLS103.
- Must demonstrate the ability to use the inhaler correctly through a training tool
(BluHale).
- Must have the ability and willingness to attend the necessary clinic visits.
Exclusion Criteria:
- A history of non-epileptic seizures (e.g. metabolic, structural or pseudo-seizures).
- Females who are pregnant or lactating.
- Individuals of reproductive potential who do not agree to use effective birth-control
methods.
- Any clinically significant laboratory abnormality which, in the opinion of the
investigator, will exclude the subject from the study.
- An active CNS infection, demyelinating disease, degenerative neurological disease or
any CNS disease deemed to be progressive during the course of the study that may
confound the interpretation of the study results.
- Any clinically significant psychiatric illness, psychological or behavioral problems
which, in the opinion of the investigator, would interfere with the subject's ability
to participate in the study.
- A history of alcoholism, drug abuse, or drug addiction within the past 12 months.
- Subjects who are suffering from clinically significant active liver disease, porphyria
or with a family history of severe hepatic dysfunction indicated by abnormal liver
function tests greater than 3 times the upper limit of normal (AST and ALT).
- Subjects who have participated in any other trials involving an investigational
product or device within 30 days of screening or longer as required by local
regulations.
- Subjects receiving more than 3 concomitant ASMs for their epilepsy.
- In the opinion of the Investigator, has a significant risk for suicidal behavior
during the course of their participation in the study, or
- At Screening (Visit 1): the subject scores "yes" on items 1 or 2 in the Suicidal
Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) with reference
to a 6-month period prior to Screening; or
- At Screening (Visit 1): the subject has had 1 or more suicidal attempts with reference
to a 2-year period prior to Screening; or
- At Visit 2 or Visit 3: the subject scores "yes" on items 1 or 2 in the Suicidal
Ideation section of the C-SSRS with reference to Screening; or
- The subject is considered to be an imminent danger to themself or others.
- Currently using marijuana, marijuana cigarettes, cannabis-related products, THC (e.g.
dronabinol, Marinol, Syndros) or CBD (e.g. Epidiolex or any over-the-counter
CBD-containing product); or have used any of these products within 3 weeks prior to
Screening (at the discretion of the Investigator in consultation with the Sponsor, to
be confirmed by a urine drug test at Screening).
- Any history of pulmonary disease, including bronchospastic respiratory disease
(bronchial asthma), or chronic obstructive pulmonary disease.
- Clinically significant abnormal values for spirometry, or hematology, serum chemistry,
or urinalysis at Screening as deemed appropriate by the Investigator, including:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 × the
upper limit of normal (ULN)
- Total bilirubin >1.5 × ULN (isolated bilirubin >1.5 ×ULN is acceptable if total
bilirubin and direct bilirubin <35%)
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or
squamous epithelial carcinomas of the skin that have been resected with no evidence of
metastatic disease for 3 years.
- Received an investigational medicinal product within 30 days or 5 half-lives prior to
Baseline, whichever is longer.
- Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2
weeks prior to Screening, including confirmed active COVID-19.
- Had major surgery (general anesthetic) in the last 3 months or minor surgery (local
anesthetic) in the last 1 month prior to Screening or have any pre-planned surgery or
procedures that would interfere with the conduct of the study.
- Is an employee of the Investigator or study site, with direct involvement in the
proposed study or other studies under the direction of that Investigator or study
site, as well as family members of the employees or the Investigator.
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