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Epileptic EncephalopathyPhase 1CARE-ENCT03024827

Cannabidiol in Children With Refractory Epileptic Encephalopathy

A Phase 1 study testing CanniMed® 1:20 in people with Epileptic Encephalopathy, run by University of Saskatchewan at 4 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period. Read more about this study

Who is it for?
Ages 1 year to 10 years
Conditions the study is for
Epileptic Encephalopathy
What is being tested?
CanniMed® 1:20
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesCanada
Study dates
26 Apr 2017to 31 Dec 2023
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 1 year to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 1-10 years
  • Epileptic Encephalopathy
  • A minimum of at least 1 major seizure per week or 4 major seizures per month. For the purposes of this research study, a major seizure would include atonic, tonic, clonic, tonic-clonic, major myoclonic, myoclonic astatic seizures and epileptic spasms (including infantile spasms)
  • Refractory to anticonvulsant medication as per the International League Against Epilepsy (ILAE) Definition of failing 2 appropriate anticonvulsants at therapeutic doses
  • The ability to attend appointments regularly
  • Negative pregnancy test at screening for females who have reached menarche

Who cannot join

  • Recent (<1 month) change in anticonvulsant therapies including anticonvulsant medications, ketogenic diet or settings on Vagal Nerve Stimulator
  • Recent (<6 months) change in intravenous immunoglobulin (IVIG) treatment
  • Initiation of ketogenic diet within 6 months (Patients must be on the ketogenic diet for at least 6 months to prevent any delayed response from the ketogenic diet affecting study results)
  • Implantation and activation of Vagal Nerve Stimulator within 12 months (Patients may have a vagal nerve stimulator for at least one year once again to prevent delayed response from the vagal nerve stimulator affecting study results)
  • Use of cannabis-based therapy within 2 months (Participants who have previously used a cannabis based therapy may be included if they have a 2 month period without use of cannabis based therapy prior to enrolment in the study)
  • Use of selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant or atypical neuroleptic medication in last month
Show all 11Show fewer
  • Concomitant regular use of narcotics (Use of narcotics in emergency situations and supervised by a physician is allowed)
  • Initiation or dosage change of oral or injected steroids within 3 months
  • Allergy or known intolerance to any of the compounds within the study preparation
  • Inability of study participants to attend assessments on a monthly basis
  • Clinically significant cardiac, renal or hepatic disease (as assessed by the site investigator)

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Universite de Montreal

    Montreal, Quebec, H3T1J4

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N5C5

  • University of British Columbia

    Vancouver, British Columbia, V6T1Z4

  • University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

About this study

Official title: Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)

This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period.

Read the detailed description

Epileptic Encephalopathies are a group of epilepsies that develop in children. These epilepsies can cause frequent and difficult to control seizures. Because of the ongoing seizures, these epilepsies can also cause cognitive impairment and neurological impairment.

In many children with these Epileptic Encephalopathies, seizures are difficult to control with medical treatment, such as anti-convulsants or non-drug treatments like the ketogenic diet (a high fat, adequate-protein, low-carbohydrate diet). This has resulted in a need to find therapies that are effective and better tolerated for children with epileptic encephalopathies.

There is very limited data regarding the use of cannabis products in children, in particular cannabidiol-enriched cannabis oil in children with epilepsy. However, hemp oil products with high cannabidiol and low tetrahydrocannabinol ratios have been reported to provide seizure relief and cognitive improvement in children who take them.

Being tested
CanniMed® 1:20
Keywords
Infantile Spasms, Lennox Gastaut Syndrome, Doose Syndrome, Continuous Spike Wave in Sleep, Landau-Kleffner Syndrome, Dravet Syndrome, Malignant Migrating Partial Seizures of Infancy (MMPSI)
Medical subject headings
Spasms, Infantile, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, Landau-Kleffner Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CanniMed® 1:20Drug

    Also called Medical Cannabis Oil

    A cannabidiol (CBD): tetrahydrocannabinol (Δ9 THC) 20:1 ratio product will be provided as an oil-based suspension.

Study groups in NCT03024827
Study groupRoleWhat they receive
Medical Cannabis OilExperimentalCanniMed® 1:20
Receives: Drug: CanniMed® 1:20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate

    Measured: Up to 6 months

  2. Blood Pressure

    Measured: Up to 6 months

  3. Weight

    Measured: Up to 6 months

  4. Complete Blood Count (CBC) and Differential

    Measured: Up to 6 months

  5. Sodium, potassium, chloride, calcium, magnesium, phosphate and carbon dioxide (mmol/L)

    Measured: Up to 6 months

  6. Blood Urea Nitrogen (mmol/L)

    Measured: Up to 6 months

  7. Creatinine (umol/L)

    Measured: Up to 6 months

  8. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) and Lipase (U/L)

    Measured: Up to 6 months

  9. Total and Direct Bilirubin (umol/L)

    Measured: Up to 6 months

  10. Albumin (g/L)

    Measured: Up to 6 months

  11. Total Cholesterol and Triglyceride (mmol/L)

    Measured: Up to 6 months

  12. Clobazam and Norclobazam Levels (umol/L)

    For participants taking clobazam who become excessively sedated

    Measured: Up to 6 months

  13. Clonazepam Level (umol/L)

    For participants taking clonazepam who become excessively sedated

    Measured: Up to 6 months

  14. Urine Ketones

    For participants on the ketogenic diet

    Measured: Up to 6 months

  15. Trough Level of Concomitant Anti-Convulsants

    Measure interactions with any anti-convulsants participants may be already on

    Measured: Up to 7 months

  16. Adverse Events

    Side effect rating scale, includes items related to sleepiness/lethargy, irritability, nausea/vomiting and diarrhea

    Measured: Through study completion, up to 7 months

  17. 2-hour Electroencephalogram (EEG) Recording

    Measured: Up to 6 months

Secondary outcomes (5)

  1. Seizure Frequency Log Book

    Measured: Through study completion, up to 7 months

  2. Modified Quality of Life in Children with Epilepsy Questionnaire (QOLCE)

    Measured: Through study completion, up to 7 months

  3. Cannabidiol (CBD) (ng/mL)

    Levels in blood

    Measured: Up to 7 months

  4. Tetrahydrocannabinol (Δ9-THC) (ng/mL)

    Levels in blood

    Measured: Up to 7 months

  5. 11-nor-9-carboxy-tetrahydrocannabinol (11-nor-9-Carboxy-THC) (ng/mL)

    Levels in blood

    Measured: Up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2017 (estimated)
  2. Study start26 Apr 2017
  3. Primary completion1 Feb 2020
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03024827
Sponsor's protocol ID
CARE-E-01
Acronym
CARE-E
Status last verified
Apr 2023
First submitted
16 Dec 2016
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reithmeier D, Tang-Wai R, Seifert B, Lyon AW, Alcorn J, Acton B, Corley S, Prosser-Loose E, Mousseau DD, Lim HJ, Tellez-Zenteno J, Huh L, Leung E, Carmant L, Huntsman RJ. The protocol for the Cannabidiol in children with refractory epileptic encephalopathy (CARE-E) study: a phase 1 dosage escalation study. BMC Pediatr. 2018 Jul 7;18(1):221. doi: 10.1186/s12887-018-1191-y.

    PubMed 29981580

  • Huntsman RJ, Tang-Wai R, Alcorn J, Vuong S, Acton B, Corley S, Laprairie R, Lyon AW, Meier S, Mousseau DD, Newmeyer D, Prosser-Loose E, Seifert B, Tellez-Zenteno J, Huh L, Leung E, Major P. Dosage Related Efficacy and Tolerability of Cannabidiol in Children With Treatment-Resistant Epileptic Encephalopathy: Preliminary Results of the CARE-E Study. Front Neurol. 2019 Jul 3;10:716. doi: 10.3389/fneur.2019.00716. eCollection 2019.

    PubMed 31333569

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CanniMed® 1:20 in people with Epileptic Encephalopathy, run by University of Saskatchewan at 4 sites in Canada.

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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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 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?

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?

Heart Rate (time frame: Up to 6 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03024827, which also lists 2 linked publications.

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 26 Apr 2023.

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