EpilepsyPhase 1NCT05678881
Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy
A Phase 1 study testing High dose RLS103 and Low dose RLS103 in people with Epilepsy, run by Receptor Life Sciences.
Trial summary
The purpose of this study is to evaluate RLS103 for safety and suppression of the epileptic photoparoxysmal response compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- High dose RLS103 and Low dose RLS103
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2022to 23 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Phase 1b Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Safety, Tolerability, and Efficacy of Two Doses of RLS103 (Inhaled Dry Powder Cannabidiol [CBD]) in a Clinical Model of Photosensitive Epilepsy
The purpose of this study is to evaluate RLS103 for safety and suppression of the epileptic photoparoxysmal response compared to placebo.
Read the detailed description
Approximately 5 subjects with a known stable photoparoxysmal response (PPR) on EEG, will be administered high dose RLS103 and placebo in a blinded, randomized, crossover design. Patient EEG responses will be compared between RLS103 and placebo. An additional low dose RLS103 may be administered to each patient in an open label period.
On study days, several procedures and intermittent photic stimulation (IPS) assessments will be performed at pre-determined times over the course of the day. After the subject completes both treatment visits, the blinded IPS data will be reviewed and analyzed by the Sponsor and the Epilepsy Study Consortium, Inc. If the blinded data on the 2 treatment days indicates a differential response, a decision will be made whether the subject will be asked to continue in the open label phase. The open label phase will consist of one visit, lasting 1 day.
- Conditions
- Epilepsy
- Being tested
- High dose RLS103, placebo inhaled powder, Low dose RLS103
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose RLS103Drug
8 mg CBD inhaled powder
placebo inhaled powderDrug
placebo inhaled powder
Low dose RLS103Drug
4 mg CBD inhaled powder (open label)
| Study group | Role | What they receive |
|---|---|---|
| High dose RLS103 | Experimental | 8 mg CBD inhaled dry powder Receives: Drug: High dose RLS103 |
| Placebo | Placebo comparator | placebo inhaled dry powder Receives: Drug: placebo inhaled powder |
| Low dose RLS103 | Experimental | 4 mg CBD inhaled dry powder (open label) Receives: Drug: Low dose RLS103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week (between Visits 2 and 3)
Change in PPR
Change in the PPR range in subjects receiving RLS103 compared to placebo
Measured: 1 week (between Visits 2 and 3)
Secondary outcomes (2)
Change in concomitant plasma ASM levels
Plasma concentrations of concomitant anti-seizure medications (ASMs) during administration of RLS103 as compared to the placebo days
Measured: 1 week (between Visits 2 and 3)
CBD pharmacokinetics
Plasma concentration of CBD at 2, 10, 30, and 60 minutes after inhalation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start25 Apr 2022
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Receptor Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Epilepsy Study Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678881
- Sponsor's protocol ID
- RC2022-02
- Status last verified
- May 2024
- First submitted
- 22 Dec 2022
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Safety, Tolerability, and Efficacy of Two Doses of RLS103 (Inhaled Dry Powder Cannabidiol [CBD]) in a Clinical Model of Photosensitive Epilepsy
- ClinicalTrials.gov ID
- NCT05678881
- Acronym / sponsor ID
- RC2022-02
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Receptor Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- The Epilepsy Study Consortium
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate RLS103 for safety and suppression of the epileptic photoparoxysmal response compared to placebo.
Detailed description
Approximately 5 subjects with a known stable photoparoxysmal response (PPR) on EEG, will be administered high dose RLS103 and placebo in a blinded, randomized, crossover design. Patient EEG responses will be compared between RLS103 and placebo. An additional low dose RLS103 may be administered to each patient in an open label period.
On study days, several procedures and intermittent photic stimulation (IPS) assessments will be performed at pre-determined times over the course of the day. After the subject completes both treatment visits, the blinded IPS data will be reviewed and analyzed by the Sponsor and the Epilepsy Study Consortium, Inc. If the blinded data on the 2 treatment days indicates a differential response, a decision will be made whether the subject will be asked to continue in the open label phase. The open label phase will consist of one visit, lasting 1 day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose RLS103 | Experimental | Drug: High dose RLS1038 mg CBD inhaled dry powder |
| Placebo | Placebo comparator | Drug: placebo inhaled powderplacebo inhaled dry powder |
| Low dose RLS103 | Experimental | Drug: Low dose RLS1034 mg CBD inhaled dry powder (open label) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose RLS1038 mg CBD inhaled powder | Drug | High dose RLS103 |
| placebo inhaled powderplacebo inhaled powder | Drug | Placebo |
| Low dose RLS1034 mg CBD inhaled powder (open label) | Drug | Low dose RLS103 |
Primary outcome
Incidence and severity of adverse events
Time frame: 1 week (between Visits 2 and 3)
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.
Change in PPR
Time frame: 1 week (between Visits 2 and 3)
Change in the PPR range in subjects receiving RLS103 compared to placebo
2 secondary outcomes
Change in concomitant plasma ASM levels
Time frame: 1 week (between Visits 2 and 3)
CBD pharmacokinetics
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High dose RLS103 and Low dose RLS103 in people with Epilepsy, run by Receptor Life Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: 1 week (between Visits 2 and 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.