Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy

NCT05678881 | Terminated Phase 1 FDA Drug

• 1 other identifier: RC2022-02
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate RLS103 for safety and suppression of the epileptic photoparoxysmal response compared to placebo.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events

  Number and severity of treatment emergent serious adverse events (TESAEs), treatment emergent adverse events (TEAEs),and adverse events (AEs) leading to discontinuation from the study.

  1 week (between Visits 2 and 3)

• Change in PPR

  Change in the PPR range in subjects receiving RLS103 compared to placebo

  1 week (between Visits 2 and 3)

Secondary Outcomes (2)

• Change in concomitant plasma ASM levels

  1 week (between Visits 2 and 3)

• CBD pharmacokinetics

  1 hour

Study Arms (3)

High dose RLS103

EXPERIMENTAL

8 mg CBD inhaled dry powder

Drug: High dose RLS103

Placebo

PLACEBO COMPARATOR

placebo inhaled dry powder

Drug: placebo inhaled powder

Low dose RLS103

EXPERIMENTAL

4 mg CBD inhaled dry powder (open label)

Drug: Low dose RLS103

Interventions

High dose RLS103 DRUG

8 mg CBD inhaled powder

High dose RLS103

placebo inhaled powder DRUG

placebo inhaled powder

Placebo

Low dose RLS103 DRUG

4 mg CBD inhaled powder (open label)

Low dose RLS103

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Receptor Life Sciences: lead
• The Epilepsy Study Consortium: collaborator

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 10, 2023
• Study Start: April 25, 2022
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share