2024-520171-27-00招募中3 期
Treatment with full-spectrum cannabis extract of refractory epilepsy associated with Tuberous Sclerosis Complex (TSC): SPECTRUM
Oils4cure S.L., Oils4cure S.L.3 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年1月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the second month of treatment with respect to the baseline period; and in patient assigned to receive a placebo, changes in the number of monthly seizures in the second month of treatment with YCJ-01 with respect to the baseline period.
研究概览
简要总结
- To assess treatment efficacy with YCJ-01 by changes in the number of epileptic seizures in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.
- To assess the safety of the treatment with YCJ-01 in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients of any sex between 2 and 65 years of age (both included)
- •Diagnosis confirmed by the TSC investigator (by clinical criteria and/or genetic study).
- •Refractory epilepsy secondary to TSC, defined as that not responding successfully to traditional AEDs (2 or more), ketogenic diet, vagal nerve stimulator, and/or whose patients are not candidate for epilepsy surgery or persist with seizures after surgery.
- •Patients with a minimum of 4 epileptic seizures or more within 4 weeks prior to the initiation of the assigned treatment in the trial, with observable external signs (loss of consciousness or motor component).
- •Stability in AEDs doses, and in ketogenic diet/programming of the device associated with the vagal nerve stimulator with no changes for at least 4 weeks prior to the initiation of the assigned treatment.
- •Patients who are in treatment with 3 or less AEDs at the time of signing the informed consent. For the purposes of assessing eligibility, Clobazam will not be counted as AED
- •Willingness by patients or caregivers/family members (in case of patients who are minors or under legal guardianship) to complete the seizure diary.
- •In case of women of child-bearing age, for safety, those who agree to follow the required contraceptive measures from the signing of the informed consent until three months after stop the intake of the investigational medicinal product.
- •Patients who have signed the informed consent either by themselves or through a legal representative.
排除标准
- •Patients who are receiving treatment on corticoids at the time of signing the informed consent.
- •Breastfeeding women
- •To have participated in another clinical trial, unless at least 5 half- lives of the investigational product have elapsed, or 12 weeks, if it is a product with cannabis oil.
- •Patients who have received products with cannabis oil in the last 12 weeks.
- •Patients who did not correctly follow the AED treatment in the 4 weeks prior to the intervention assigned in the trial.
- •Patients who changed medication or AED dose, ketogenic diet, or the vagal stimulator during the 4 weeks prior to the initiation of the intervention assigned in the trial.
- •Cardiac, renal, and hepatic failure, pancreatic insufficiency, or hematologic dysfunction with values above the normal limits of creatinine and urea; values 2 times the normal limits of transaminases, lipases, and serum amylase; platelets < 80000/mm3, and white blood cell count <3000/mm
- •Uncontrolled severe medical condition such as: hepatic disease, increased bilirubin levels more than twice the normal limit, cirrhosis, chronic hepatitis (hepatitis B or C), uncontrolled diabetes (defined as blood glucose >150 mg%), (chronic or acute) active infections or uncontrolled severe infections, or active bleeding.
- •Patients or family/caregivers (in case of patients who are minors or under legal guardianship) who does not agree to comply with the requirements and trial visits or present a high risk of non-compliance with the protocol, according to the treating physician.
- •Allergy to any of the components of the investigational medicinal product/placebo.
- •Family (considering only first-degree blood relatives) or personal history of schizophrenia.
- •Personal history of suicide attempts.
结局指标
主要结局
Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the second month of treatment with respect to the baseline period; and in patient assigned to receive a placebo, changes in the number of monthly seizures in the second month of treatment with YCJ-01 with respect to the baseline period.
Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the second month of treatment with respect to the baseline period; and in patient assigned to receive a placebo, changes in the number of monthly seizures in the second month of treatment with YCJ-01 with respect to the baseline period.
Occurrence of Adverse Events (AE), Severe AE (SAE), AE resulting in study treatment withdrawal, AE of special interest (AESI), and changes in vital signs and laboratory values during the clinical trial. (Variable associated to the primary objective 2).
Occurrence of Adverse Events (AE), Severe AE (SAE), AE resulting in study treatment withdrawal, AE of special interest (AESI), and changes in vital signs and laboratory values during the clinical trial. (Variable associated to the primary objective 2).
次要结局
- Comparison of the number of monthly epileptic seizures between the two treatment groups and the baseline period: change in number of monthly seizures of patients assigned to receive the investigational medicinal product during the second month of treatment (from visit P2 to P3) with respect of the baseline period (from visit P0 to P1), in comparison to the second month of treatment (from visit P2 to P3) to the group receiving placebo with respect to the baseline period (from visit P0 to P1).
- Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the months of treatment after the second month of treatment with respect to the baseline period; and in patients assigned to receive placebo, changes in the number of monthly seizures in the months of treatment after the second month of treatment with YCJ-01 with respect to baseline
- Comparison of the number of monthly seizures once the final dose was reached in P4-P5 with respect to the baseline period (from visit P0 to P1) in each of the patients. (Variable associated with primary objective 1).
- Response rate to YCJ-01: patients who achieve a decrease of at least a 50 % of the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) in visits P3, P4, P6, and P7 will be considered responders. (Variable associated to the secondary objective 1).
- Response rate to YCJ-01in comparison to the placebo group: patients who achieve a decrease in at least a 50 % of the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) in visit P3 will be considered responders. (Variable associated to the secondary objective 1).
- Proportion of subjects in treatment with YCJ-01 achieving a 25%, 50%, 75%, 90% reduction in the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) at visits P3, P4, P6, and P7. (Variable associated to the secondary objective 2).
- Proportion of subjects in treatment with YCJ-01 compared to placebo group achieving a 25%, 50%, 75%, 90% reduction in the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) at visit P3. (Variable associated to the secondary objective 2).
- Proportion of patients in treatment with YCJ-01 free of epileptic seizures: defined as those participants with no seizure of any type from the initiation of the treatment with YCJ-01 till visit P7, or a period of time that doubles the baseline maximum interval between seizures (International League Against Epilepsy, ILAE). (Variable associated with the secondary objective 3).
- Proportion of patients in treatment with YCJ-01 free of epileptic seizures in comparison to the placebo group: defined as those participants with no seizure of any type from the initiation of the assigned treatment till visit P7, or a period of time that doubles the baseline maximum interval between seizures (International League Against Epilepsy, ILAE). (Variable associated with the secondary objective 3).
- Effect on control of epileptic seizures (variable associated to the secondary objective 4): Changes in severity and in types of epileptic seizures will be assessed after the initiation of the treatment (from visit P1 to P2, from visit P2 to P3, from visit P3 to P4, from visit P4 to P5, from visit P5 to P6, from visit P6 to P7) with respect to the baseline period (form visit P0 to P1).
研究者
Carmen Sever Bermejo
Scientific
Oils4cure S.L.
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset SeizuresPartial EpilepsyNCT01397968SK Life Science, Inc.222
已完成
2 期
Efficacy of YKP3089 in Patients With Photosensitive EpilepsyEpilepsyNCT00616148SK Life Science, Inc.11
已完成
1 期
A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and PlasmaHealthyNCT02933762Janssen Research & Development, LLC25
招募中
1 期
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple MyelomaMultiple MyelomaNCT06768489Janssen Research & Development, LLC240
招募中
1 期
A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell CarcinomaNCT07219212Johnson & Johnson Enterprise Innovation Inc.45