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IRCT20210608051515N1 IRCT 2021-06-12 Tehran University of Medical Sciences Canabidiol (CBD) for Treatment of Frontal Lobe Epilepsy Efficacy of Cannabidiol (CBD) in Patients with Treatment-Resistant Frontal Lobe Epilepsy 2021-07-21 anticipated 30 Complete https://irct.ir/trial/56790 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization coincides with the allocation concealment by generating random codes - consisting of an English letter and two digits - generated using one of the web resources (here is random.org), printing the codes on a card, and placing the cards in a sealed envelope (SNOSE method). After generating the code list, fifteen codes will be assigned to the drug group, and the other fifteen codes are assigned to the placebo group (alternately assigned). This list will be delivered to the drug supplier, and each code is displayed properly as a label on the body of the drug box or placebo. Each code will be printed on one card that, after shuffling, are placed in opaque envelopes with aluminum inner lining numbered from 1 to 30, and the envelope lid will be completely sealed. The envelopes will be placed in a box and handed over to another researcher responsible for delivering the drugs to the participants. The patients who will be referred to assign to one of the two groups will be given an envelope. The envelope will be taken out of the box orderly, and the seal will be broken. According to the code in the envelope, the right drug box or placebo is delivered to the patient, and the patient's credentials are written on the envelope. Also, in a separate list, the person is assigned to the code taken out of the envelope. Thus, subsequent visits for re-delivery of the box containing a drug or placebo will be done precisely based on their code. In contrast, the researcher responsible for allocating patients and the participant themselves will not be aware of the type of intervention they will offer and receive. (Generating of the codes and assigning half of the codes to the intervention and the other half to the control will be done by another researcher who will not be responsible for these steps or any other steps), Blinding description: Study participants will all be unaware of their group (drug or placebo) even though they know they will participate in a study that they will be given one of the two options: drug or placebo. Also, patients and personnel are completely blinded due to the exact similar label and specifications on boxes, color, taste, smell, and consistency between the drug and placebo. Clinical caregivers, researchers, and physicians responsible for diagnosis and treatment will be unaware of the type of treatment assigned to each participant. Those responsible for evaluating the results will also evaluate data and perform the statistical analysis by coding individuals without being aware of the patient group - drug or placebo. The Data Safety and Monitoring Committee is also unaware of people who have received the drug or placebo and only monitors the above-mentioned principles according to blinding، concealment, and data collection protocols. 3 Treatment Resistant Epilepsy. Intervention 1: Intervention group: Patients diagnosed with frontal lobe epilepsy who are resistant to common drug therapies. These patients are randomly assigned to the intervention group according to the conditions previously described. Cannabidiol in liquid form containing 40 mg per ml of the active substance (Cannabidiol or CBD) with an appropriate amount of preservatives and flavorings according to the protocol prepared by Khosro Medisa-Teb (KMT) pharmaceutical company. It will be prescribed 70 mg (equivalent to 1.75 ml) in the first week, then 140 mg (equivalent to 3.5 ml) in the second week, and 210 mg (equivalent to 5.25 ml) in the third to fourteenth weeks as a single dose (Daily - qDay). From the beginning of the intervention, the patient continues to take the drug for fourteen weeks, and the necessary evaluations will be performed at intervals according to the predefined schedule. The way to take the drug, which is in liquid form and should be taken using a graduated dropper embedded in the medicine package, will be fully explained by the person delivering the medicine. Intervention 2: Control group: Patients diagnosed with frontal lobe epilepsy who are resistant to common drug therapies. These patients are randomly assigned to the control group according to the previously described conditions. Placebo will be prepared according to the specific protocol of Khosro Medisa-Tab (KMT) Pharmaceutical Company, which is in the form of liquid without active ingredient (Cannabidiol or CBD) and contains an appropriate amount of preservatives and flavorings. It is the same in terms of color, smell, consistency, and taste as the drug. This product will be prescribed in the first week equal to 1.75 ml and then in the second week equal to 3.5 ml and the third week until the fourteenth week equal to 5.25 ml as a single dose (daily - qDay). From the beginning of the placebo administration, the patient continues to take the placebo for fourteen weeks, and the necessary evaluations are performed at intervals according to the specified schedule. The way to take medicine, which is in liquid form and should be taken using a graduated dropper embedded in the medicine package, will be fully explained by the person delivering the medicine. Yes - There is a plan to make this available What will be shared: The data of the study participants will be evaluated for statistical analysis, and their results will be published in the form of an article. When: Immediately after the publication of the results in the form of a scientific article, the results of data analysis will be available to researchers at the request of the data. To whom: Researchers of this project and individuals who have the right to access the project data based on the written permission of the corresponding researcher can access the project data. Conditions: If the permission of the main researcher of the project is obtained with an acceptable justification and explanation, the data obtained from this project can be used. Where to obtain: Imam Khomeini Hospital Complex, Neurological Diseases Research Center, Second Floor, Epilepsy Monitoring Unit, Research Unit How to obtain: A written request will be sent to the researcher in charge of the study (Dr. Abbas Tafakhori) with appropriate evidence and justification; Once approved by him, access to data and documents will be possible. Comments:
public Seyyed Reza Ebadi
No. 7, 3rd Block, Maahtaab Ave., Aftaab Ave., Khodammi Ave., Vanak.,
Tehran Iran (Islamic Republic of) 1994964811 +98 21 8821 2409 seyyedrezae@gmail.com Tehran University of Medical Sciences scientific Abbas Tafakhori
Qadr Ave., North Karegar Ave., Enqelab Sq., Tehran, Tehran
Tehran Iran (Islamic Republic of) 1415983111 +98 21 6687 9867 abbas.tafakhori@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Drug resistant frontal lobe epilepsy diagnosis (Insufficient or no response to two or more of anti epileptic agents) 18 years no limit Both Consumption of any derivative of marijuana or cannabis plant in recent month Pregnancy Any of the aforementioned medications in regimen: Clobazam, DesMethyl Clobazam, Eslicarbazepin, Topiramate, Zonisamide, Warfarin G40 Epilepsy and recurrent seizures Treatment - Drugs Treatment - Drugs Intervention group: Patients diagnosed with frontal lobe epilepsy who are resistant to common drug therapies. These patients are randomly assigned to the intervention group according to the conditions previously described. Cannabidiol in liquid form containing 40 mg per ml of the active substance (Cannabidiol or CBD) with an appropriate amount of preservatives and flavorings according to the protocol prepared by Khosro Medisa-Teb (KMT) pharmaceutical company. It will be prescribed 70 mg (equivalent to 1.75 ml) in the first week, then 140 mg (equivalent to 3.5 ml) in the second week, and 210 mg (equivalent to 5.25 ml) in the third to fourteenth weeks as a single dose (Daily - qDay). From the beginning of the intervention, the patient continues to take the drug for fourteen weeks, and the necessary evaluations will be performed at intervals according to the predefined schedule. The way to take the drug, which is in liquid form and should be taken using a graduated dropper embedded in the medicine package, will be fully explained by the person delivering the medicine. Control group: Patients diagnosed with frontal lobe epilepsy who are resistant to common drug therapies. These patients are randomly assigned to the control group according to the previously described conditions. Placebo will be prepared according to the specific protocol of Khosro Medisa-Tab (KMT) Pharmaceutical Company, which is in the form of liquid without active ingredient (Cannabidiol or CBD) and contains an appropriate amount of preservatives and flavorings. It is the same in terms of color, smell, consistency, and taste as the drug. This product will be prescribed in the first week equal to 1.75 ml and then in the second week equal to 3.5 ml and the third week until the fourteenth week equal to 5.25 ml as a single dose (daily - qDay). From the beginning of the placebo administration, the patient continues to take the placebo for fourteen weeks, and the necessary evaluations are performed at intervals according to the specified schedule. The way to take medicine, which is in liquid form and should be taken using a graduated dropper embedded in the medicine package, will be fully explained by the person delivering the medicine. Decrease in the seizure frequency in drug-resistant frontal lobe epilepsy following cannabidiol use. Timepoint: Before the intervention and after 14 weeks of taking the drug or placebo. Method of measurement: Based on the patient's history and counting the number of seizures per month. Decrease in the severity of seizures after taking cannabidiol according to the Chalfont seizure severity scale. Timepoint: Before the intervention and after fourteen weeks of taking drug or placebo. Method of measurement: Based on the Chalfont seizure severity by scoring system. Increase in quality of life in epilepsy following cannabidiol use. Timepoint: Before the intervention and after the fourteen weeks of taking medication or placebo. Method of measurement: Quality of Life in Epilepsy with 31 questions (QOLIE-31) questionnaire by scoring. KMT Pharmaceutical Company Approved 2021-05-01 School of Medicine-Tehran University of Medical Sciences, Biomedical Research Ethics Committee Room 605، Secretariat of the Ethics Committee in University Biomedical Research، Vice Chancellor for Research and Technology, 6th Floor, Central University Organization, Corner of Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)