EUCTR2007-002874-75-IT进行中（未招募）不适用
Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •1. Patients and/or their legally authorised representative (LAR) must have signed and dated the Informed Consent Form approved by the Ethics Committee of the structure where they are cured;
- •2. Participation in the previous Ovation sponsored study on the psychosis of Parkinson?s Disease with melperone.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients remaining more than 14 days without treatment from when the last dose of the experimental medication was taken in the previous Ovation sponsored study on psychosis in PD;
- •2. Patients having serious or severe adverse effects in the previous Ovation sponsored study on psychosis in PD which, in the opinion of the Investigator, was probably or certainly connected to the use of the melperone;
- •3. History of serious cardiovascular conditions (including, for simplicity but not limited to, class IV angina or class IV heart failure) and/or of risk factors for Torsade de pointes (Tdp) (including for simplicity but not limited to, current treatment for hypokalemia or family history of long QT syndrome);
- •4. During the previous Ovation sponsored study on psychosis in PD, the patient had an ECG with a corrected QT interval with the Bazett formula, of more than 450 msec if female, 430 msec if male. If the patient had an ECG greater than 450 msec if female, or 430 if male, then he/she may take part in the new study as long as:
- •a. the patient did not have a value of QTc greater than 500 msec during the double-blind study;
- •b. the patient's QTc was ≤450 msec if female, or ≤430 msec if male, at Day 43 (for patients under treatment with 4 ml of experimental drug) or at the Final Visit of the double-blind study.
- •i. Patients who have had a QTc >450 msec if female, or >430 msec if male at Day 43 or at the Final Visit may be eligible in the new study if they gradually reduce the dose of the drug to 0 ml, return to repeat the ECG and this new ECG shows a QTc ≤450 msec if female, or ≤430 msec if male.
- •5. Patients requiring therapy with an alpha-agonist agent.
研究者
相似试验
进行中（未招募）
不适用
Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease.EUCTR2007-000307-15-ITOVATION PHARMACEUTICALS INC90
招募中
1 期
Evaluation of the Safety of Olprinone for Low Central Venous Pressure Management during Laparoscopic HepatectomyHepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Metastatic liver cancer, Perihilar cholanJPRN-jRCTs041230110Sugiura Teiichi30
尚未招募
4 期
Melagenina Plus - Vitiligo – phase IVVitiligoPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesSkin PigmentationHypopigmentationRPCEC00000297Placental Histotherapy Center Dr. Carlos Manuel Miyares Cao (CHP)244
进行中（未招募）
1 期
Clinical study to find out the safety and efficacy of a polyherbal local anaesthetic parenteral formulatioCTRI/2022/04/042091Pankajakasthuri Herbals India Pvt Ltd
招募中
4 期
A clinical trial to study the effects of three drugs, Mephentermine, Ephedrine and Phenylephrine on Post Subarachnoid Block Hypotension during Lower Segment Caesarean Section (LSCS).CTRI/2015/10/006255Govt Medical College Department of Pharmacology Bhavnagar150