EUCTR2020-002822-10-IT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
- 480
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
- •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
- •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 giving 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 liver and 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 nonallowed 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 halflives (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
- 另有 8 项未显示
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