EUCTR2020-002822-10-NL进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 499
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Main study:
- •1. Twenty-five years of age (inclusive) and older, at the time of signing the informed consent.
- •2. Diagnosis of HD based on clinical features and the presence of =36 CAG repeats in the HTT, confirmed by historical laboratory quantified results or by a diagnostic test at screening.
- •3. Diagnostic confidence level (DCL) of 4 (unequivocal motor signs, = 99% confidence) on the standardized motor exam UHDRS-TMS.
- •4. Adult-onset HD with onset of signs and symptoms =18 years of age.
- •5. Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of =7, at screening.
- •6. UHDRS-Independence scale (IS) score =90% at screening.
- •7. UHDRS-TMS =20 at the Screening visit.
- •8. Must meet all criteria required to move forward with the Randomization Authorization Flow (RAF) and be considered eligible by the RAF Reviewer.
- •9. Male or female.
- •10. Female participants of childbearing potential must have a negative ß-human chorionic gonadotropin (ß-HCG) test at screening and baseline, be sterile, or be postmenopausal.
- •11. Female participants of childbearing potential whose male partners are potentially fertile (i.e., no vasectomy) must use highly effective birth control methods stable for at least 3 months prior to screening, for the duration of the study and for 30 days after discontinuation of the study drug.
- •12. Male participants must be sterile, or if they are potentially fertile/reproductively competent (not surgically [e.g., vasectomy] or congenitally sterile) and their female partners are of childbearing potential, they must use, together with their female partners, effective birth control methods for the duration of the study and for 90 days after study drug discontinuation.
- •13. For participants taking allowed antipsychotic, antidepressant, or other psychotropic medication, the dosing of medication as listed in Section 10.6, must be stable for at least 4 weeks before the Baseline visit and throughout the study (unless clinically necessary to change).
- •14. Capable of providing signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Open-label Extension:
- •1. Completed the EoS visit of the Main study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Prolonged QTcF interval (defined as a QTcF interval of >450 ms for male and >470 ms for female) at screening.
- •2. Clinically significant heart disease within 12 weeks before randomization, defined as follows:
- •a. Participants with clinically significant heart disease, a clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or confirmed ventricular tachycardia, or presence of left bundle branch block.
- •b. Participants with a known history of congenital long QT syndrome or a first degree relative with this condition.
- •c. Heart rate <50 beats per minute, sick sinus syndrome, complete
- •atrioventricular block, congestive heart failure, polymorphic ventricular tachycardia, clinically relevant hypocalcemia, hypokalemia or hypomagnesemia.
- •3. History of epilepsy or seizures within the last 5 years.
- •4. Serious medical illness (includes, but not limited to, uncontrolled hypertension; respiratory disease, including severe forms of asthma; severe hepatic disease (confirmed Hepatitis B virus [HBV], Hepatitis C virus [HCV];, confirmed human immunodeficiency virus [HIV]); renal disease; acquired immune deficiency syndrome; and unstable psychiatric or other neurologic disorders) and metastatic cancer. For serious kidney and and liver liver illnesses see also exclusion criterion 12 (laboratory test abnormalities)
- •5. Known intracranial neoplasms, vascular malformations, history of cerebrovascular accident, or intracranial hemorrhage.
- •6. Female participants who are pregnant, planning to become pregnant or breastfeeding
- •7. Medications that prolong QT interval, taken within 4 weeks of the Baseline visit (note, Amiodarone is not allowed within 6 weeks of the Baseline visit) or at any timepoint during the study, including non-allowed antipsychotic medications, tricyclic antidepressants, and/or Class I antiarrhythmics
- •8. Use of pridopidine within 12 months before the Baseline visit.
- •9. Treatment with any investigational product within 6 weeks or 5 half-lives (whichever is longer) before the Screening visit or a plan to participate in another clinical study that assesses any investigational product during the study.
- •10. Gene therapy at any time
- •11. Laboratory values that fall outside of the central laboratory’s reference range at screening and are considered clinically significantly abnormal by the Investigator, and affect the participant's suitability to participate in the study or put the participant at risk if he/she enters the study in the Investigator’s opinion.
- •12. Have any of the following laboratory test abnormalities at screening
- •a. CrCl <30 mL/min at screening, calculated using the CockcroftGault equation: (140–age) × mass (kg) × [0.85 if female] / 72 × serum creatinine (mg/dL).
- •b. Aspartate aminotransferase (AST) =2.5 × upper limit of normal (ULN)
- •c. Alanine aminotransferase (ALT) =2.5 × ULN
- •d. Gamma- glutamyl transferase (GGT) =3.0 × ULN
- •e. Total bilirubin >1,5 mg/dL
- •13. Alcohol and/or substance abuse disorder within the 6 months prior to screening, as defined by the Diagnostic and Statistical Manual–Fifth Edition (DSM-5) Text Revision criteria for substance abuse.
- •14. Active suicidal ideation as measured by a most severe suicide ideation score of 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS, or participants who answered Yes” on any of the 5 C-SSRS Suicidal Behavior Items (actual attem
研究者
相似试验
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856EUCTR2018-003985-15-PTArena Pharmaceuticals Inc.433
进行中（未招募）
1 期
A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisGeneralized myasthenia gravisMedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2019-000968-18-CZCB Biopharma SR240
进行中（未招募）
1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyHomologous recombination deficiency advanced ovarian cancerMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000952-11-ITTESARO, INCORPORATED733
进行中（未招募）
1 期
A Clinical trial to evaluate safety, and effectiveness of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)onalcoholic Steatohepatitis (NASH)MedDRA version: 20.1 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disordersEUCTR2016-004148-13-PTGilead Sciences, Inc.800
招募中
1 期
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864ung Cancer, Non-Small CellMedDRA version: 21.1Level: PTClassification code: 10029521Term: Non-small cell lung cancer stage IIIB Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864CTIS2023-508443-40-00Glaxosmithkline Research & Development Limited644