NL-OMON54862撤回3 期
A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis. - ADORE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 18 * 80 years (both inclusive), male or female;
- •2. Diagnosis of definite, probable, probable laboratory supported or possible
- •ALS as based on the El Escorial and the revised Airlie House diagnostic
- •criteria for ALS;
- •3. Onset of first symptoms* no longer than 24 months prior to randomization;
- •*Date of onset is the date the patient reported one or more of the following
- •symptoms: * Muscle weakness in limbs * Speech/swallowing difficulties *
- •Respiratory symptoms: dyspnea was noticed
- •4. Slow Vital Capacity (SVC) equal to or more than 70% of the predicted normal
- •value for gender, height and age at screening visit;
- •5. Change in ALSFRS-R score between 0.35 points and 1.5 points per month (both
- •inclusive) in the period from onset of first symptoms to the Screening visit;
- •6. Patients on riluzole should be on stable doses *30 days prior to the
- •baseline visit and this dose should be maintained during the entire trial.
- •7. A female subject should not be able to become pregnant and needs to meet at
- •least one of the following criteria:
- •* female subject who is not of reproductive potential is eligible without
- •requiring the use of contraception. A woman is considered not having
- •childbearing potential when becoming post-menopausal unless permanently
- •sterile. Permanent sterilisation methods include hysterectomy, bilateral
- •salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as
- •no menses for 12 months without an alternative medical cause.
- •* female who is of reproductive potential and has a negative pregnancy test at
- •screening and at baseline and is non-lactating. A female subject who is of
- •reproductive potential agrees to use (or have their partner use) or practicing
- •adequate birth control methods starting from the time of consent through 30
- •days after the last dose of study therapy. Longer periods of birth control may
- •be required per local requirements. Acceptable methods of birth control include
- •combined (estrogen and progestogen containing) hormonal contraception
- •associated with inhibition of ovulation (oral, intravaginal, transdermal),
- •progestogen-only hormonal contraception associated with inhibition of ovulation
- •(oral, injectable, implantable), , intrauterine device in place for *3 months,
- •intrauterine hormone-releasing system, bilateral tubal occlusion or
- •vasectomised partner.
- •8.A male patient must:
- •* agree he will not donate sperm during the study and until 104 days after the
- •last dose, AND
- •* use a condom during sexual intercourse with pregnant or non-pregnant women of
- •childbearing
- •potential (WOCBP) partner even if he is vasectomized
- •* in addition WOCBP partner of the male patient must use the following
- •acceptable methods of birth control during the study and until 104 days after
- •the last dose: hormonal contraception (oral, implanted, injected or other
- •hormonal (e.g., patch or contraceptive ring) contraception), intrauterine
- •device in place for *3 months, barrier method in conjunction with spermicide OR
- •use of appropriate
- •double barrier contraception as per local regulations or guidelines;
- •9. Capable of providing informed consent and complying with trial procedures.
排除标准
- •1. Diagnosis of Primary Lateral Sclerosis;
- •2. Diagnosis of Frontotemporal Dementia;
- •3. Diagnosis of other neurodegenerative diseases (e.g. Parkinson disease,
- •Alzheimer disease);
- •4. Diagnosis of polyneuropathy;
- •5. Other causes of neuromuscular weakness;
- •6. Have a significant pulmonary disorder not attributed to ALS and/or require
- •treatment interfering with the evaluation of ALS on respiratory function;
- •7. Use of intravenous (IV) edaravone within 6 months of the screening visit;
- •8. Depend on mechanical ventilation (invasive or non-invasive) or require
- •tracheostomy at Screening;
- •9. Renal impairment as indicated by a creatinine clearance of less than 50
- •mL/min as calculated by the Cockcroft Gault equation;
- •10. Subject has a history of clinically significant hepatic disease, hepatitis
- •or biliary tract disease, or subject has a positive screening test for HIV,
- •hepatitis B or C;
- •11. Presence of any of the following clinical conditions: a. Unstable cardiac,
- •pulmonary, endocrine, hematologic or active infectious disease b. Unstable
- •psychiatric illness defined as psychosis, untreated major depression within 90
- •days of the screening visit c. Significant cognitive impairment, clinical
- •dementia or psychiatric illness d. Cancer that is currently under active
- •treatment or is likely to require treatment during the trial that may alter the
- •subject*s function and interfere with assessment of ALS disease progression.
- •12. Any comorbidity that may interfere with the functions as scored with the
- •13. History of known sensitivity or intolerability to edaravone, to any related
- •compound, or to any of the excipients;
- •14. Exposure to any investigational drug within 30 days of the screening visit;
- •15. Current substance or alcohol dependence.
研究者
相似试验
进行中（未招募）
1 期
A study to investigate the efficacy, safety, and pharmacokinetics (PK) of enzastaurin for the prevention of arterial events in patients with vEDS confirmed with COL3A1 mutationsvascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutationsMedDRA version: 20.0Level: PTClassification code 10014316Term: Ehlers-Danlos syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-006574-23-NLAytu BioPharma, Inc.260
进行中（未招募）
1 期
A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrentMedDRA version: 21.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem Organ Class: 100000004855EUCTR2018-002823-41-ATActelion Pharmaceuticals Ltd280
进行中（未招募）
1 期
EVOLVE-FD: Effects of EVOLocumab VErsus placebo added to standard lipid-lowering therapy on fasting and post fat load lipids in patients with Familial DysbetalipoproteinemiaFamilial DysbetalipoproteinemiaEUCTR2018-003476-12-NLniversity Medical Center Utrecht30
进行中（未招募）
1 期
A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease.Patients with genetically ascertained Unverricht-Lundborg disease (ULD).MedDRA version: 8.1Level: LLTClassification code 10054894Term: Unverricht-Lundborg diseaseEUCTR2006-000169-12-FRCB S.A.42
进行中（未招募）
1 期
Efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failureAcute heart failureEUCTR2013-001498-25-ATovartis Pharma Services AG6,800