Epilepsy IntractablePhase 2NCT02987114
A Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy
A Phase 2 study testing PLT101 in people with Epilepsy Intractable, run by PhytoTech Therapeutics, Ltd. at 1 site in Israel.
Trial summary
To evaluate the safety, tolerability and efficacy of oral administration of PTL101 (cannabidiol) for the treatment for pediatric intractable epilepsy. Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow up. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Epilepsy Intractable
- What is being tested?
- PLT101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Feb 2017to 28 Jun 2018
- Phase
- Phase 2
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric subjects with refractory epilepsy
- 2-15 years old (inclusive), male or female
- History of the any of the following seizure types: tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized, complex partial seizures and drop attacks (tonic/atonic).
- At least four clinically countable seizures within 4 weeks of study entry [tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized and/or complex partial seizures and drop attacks (tonic/atonic)]
- Subject on a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
- History of treatment with at least four AEDs, including one trial of a combination of two concomitant drugs, without successful seizure control
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- Subjects with vagal nerve stimulation system must be on stable settings for a minimum of 6 months prior to enrollment
- For subjects undergoing dietary treatment (e.g., ketogenic or modified Atkins diet):
- the fat to carbohydrate ratio must be stable for a minimum of eight weeks prior to enrollment
- The subject's legal guardian voluntarily provides consent for participation in the study and signs an Informed Consent Form
- Completed seizures diary for four weeks (±3 days) prior to initiation of the dose titration period (visit 2). Subject will be considered a screen failure if seizures diary was not appropriately completed.
Who cannot join
- The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
- Subject is unwilling to abstain from use of cannabis-based or synthetic cannabinoid throughout the study period
- Neurodegenerative or deteriorated neurological disease
- History of heart failure
- Known family history (first-degree) of psychiatric disorders
- Psychosis or past psychotic event and/or anxiety disorder
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- Current or history of drug abuse/addiction
- Renal, hepatic (ALT/AST >2x upper limit of normal (ULN), bilirubin >2x ULN), pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
- Clinically significant finding in baseline ECG
- Initiation of felbamate treatment within 9 months of screening
- Allergy to CBD or any cannabinoid and/or formulation excipients
- Subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
- Subject and legal guardian/caregiver unable to comply with study visits/requirements
- Subject is currently enrolled in, or has not yet completed a period of at least 60 days since ending another investigational device or drug trial(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open-label, Single-center Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy
To evaluate the safety, tolerability and efficacy of oral administration of PTL101 (cannabidiol) for the treatment for pediatric intractable epilepsy.
Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow up.
Read the detailed description
This is an open-label, single-center study recruiting approximately 15 male or female pediatric (ages 2-15, inclusive) patients with, intractable epilepsy, on stable doses of antiepileptic drugs (AEDs). The study comprised of the following period: 4 weeks observation period, followed by a 2-week dose titration period, 10-week maintenance treatment period, and a 2-week follow-up of which 1 week is a tapering-off period. Seizures will be recorded by the legal guardian/caregiver in seizure diaries throughout the first 16 weeks of the study.
- Conditions
- Epilepsy Intractable
- Being tested
- PLT101
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLT101Drug
PTL 101 (Cannabidiol, CBD) Two piece hard capsules filled with seamless gelatin matrix green beads containing CBD (50 or 100 mg CBD per capsule) The beads should be administered following a meal, mixed with food
| Study group | Role | What they receive |
|---|---|---|
| PLT101 | Experimental | PTL101 capsules (50 or 100 mg CBD per capsule) up to 25 mg/kg/day or up to 450 mg/day, the lower of the two. Twice daily (morning and evening). Receives: Drug: PLT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of study treatment related adverse events (AEs)
Measured: 12 weeks of treatment + 2 weeks follow up
Percent change in mean countable monthly seizure frequency
Measured: 12 week treatment period
Secondary outcomes (3)
Incidence of all adverse events (AEs)
Measured: 12 weeks of treatment + 2 weeks follow up
assessment of Caregiver Global Impression of Improvement using a 5-point rating scale
Measured: after 5 weeks of maintenance dose and at end of treatment
assessment of Caregiver Global Impression of Seizure Severity using a 5-point rating scale
Measured: after 5 weeks of maintenance dose and at end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start13 Feb 2017
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoTech Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987114
- Sponsor's protocol ID
- CS-100
- Status last verified
- Sep 2017
- First submitted
- 6 Dec 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Single-center Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy
- ClinicalTrials.gov ID
- NCT02987114
- Acronym / sponsor ID
- CS-100
- Conditions
- Epilepsy Intractable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PhytoTech Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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.
To evaluate the safety, tolerability and efficacy of oral administration of PTL101 (cannabidiol) for the treatment for pediatric intractable epilepsy.
Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow up.
Detailed description
This is an open-label, single-center study recruiting approximately 15 male or female pediatric (ages 2-15, inclusive) patients with, intractable epilepsy, on stable doses of antiepileptic drugs (AEDs). The study comprised of the following period: 4 weeks observation period, followed by a 2-week dose titration period, 10-week maintenance treatment period, and a 2-week follow-up of which 1 week is a tapering-off period. Seizures will be recorded by the legal guardian/caregiver in seizure diaries throughout the first 16 weeks of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLT101 | Experimental | Drug: PLT101PTL101 capsules (50 or 100 mg CBD per capsule) up to 25 mg/kg/day or up to 450 mg/day, the lower of the two. Twice daily (morning and evening). |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Pediatric subjects with refractory epilepsy
- 2-15 years old (inclusive), male or female
- History of the any of the following seizure types: tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized, complex partial seizures and drop attacks (tonic/atonic).
- At least four clinically countable seizures within 4 weeks of study entry [tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized and/or complex partial seizures and drop attacks (tonic/atonic)]
- Subject on a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
Key exclusion criteria (14 listed)
- The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
- Subject is unwilling to abstain from use of cannabis-based or synthetic cannabinoid throughout the study period
- Neurodegenerative or deteriorated neurological disease
- History of heart failure
- Known family history (first-degree) of psychiatric disorders
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 |
|---|---|---|
| PLT101PTL 101 (Cannabidiol, CBD) Two piece hard capsules filled with seamless gelatin matrix green beads containing CBD (50 or 100 mg CBD per capsule) The beads should be administered following a meal, mixed with food | Drug | PLT101 |
Primary outcome
Incidence of study treatment related adverse events (AEs)
Time frame: 12 weeks of treatment + 2 weeks follow up
Percent change in mean countable monthly seizure frequency
Time frame: 12 week treatment period
3 secondary outcomes
Incidence of all adverse events (AEs)
Time frame: 12 weeks of treatment + 2 weeks follow up
assessment of Caregiver Global Impression of Improvement using a 5-point rating scale
Time frame: after 5 weeks of maintenance dose and at end of treatment
assessment of Caregiver Global Impression of Seizure Severity using a 5-point rating scale
Time frame: after 5 weeks of maintenance dose and at end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLT101 in people with Epilepsy Intractable, run by PhytoTech Therapeutics, Ltd. at 1 site in Israel.
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 11 inclusion and 14 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: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of study treatment related adverse events (AEs) (time frame: 12 weeks of treatment + 2 weeks follow up). 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 6 Sep 2018; AzTrials last refreshed its copy on 1 Nov 2026.