EUCTR2008-007845-29-DE进行中（未招募）不适用
Prospective, randomized, double-blind study, parallel-group, multi-center trial assessing the effects of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy (HARMONY II) - Harmony II
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Bioprojet
- 入组人数
- 40
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. Males and females of any ethnic origin, 18 years old and over.
- •2. De novo patients i.e. with newly diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy. Patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
- •3. Partial or total cataplexy attacks with a frequency of at least 5 per week during a 14-day baseline period and Epworth Sleepiness Scale (ESS) score = 14/24 at the end of baseline period (V2).
- •4. The patient has expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning protocol required procedures.
- •5. Women must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control. These women must use oral contraceptives containing at least 0.05 mg Ethinyl estradiol since the effectiveness of steroidal contraceptives may be reduced when used with Modafinil. The steroidal contraceptives at micro and mini doses should be excluded. Patients should agree to continue this method for the duration of the study and for one month after thediscontinuation of Modafinil treatment. Women should be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding patient.
- •6. In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests).
- •7. Patients should be warned that change in tratment as a consequence of inclusion in this study may reduce their ability to drive as well as his / her impaired ability to operate machinery. If indicated by investigator, the patient must be willing to not operate a car or heavy machinery for the duration of the trial or as long as the investigator deems clinically indicated. In addition, the patient should be willing to maintain during the study their usual behaviours which could affect their diurnal sleepiness (e.g., circadian rhythm, caffeine consumption, nocturnal sleep duration).
- •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. The use of BF2.649 or any previous investigational drugs within 30-day period prior to initial screening visit (V1) for this trial.
- •2. Patients who are unable or unwilling to temporarily discontinue non authorized drugs or substances.
- •3. Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- •4. Any significant abnormality in the physical examination or clinical laboratory results (e.g. liver or kidney function deficiency).
- •5. Patients with severe depression (BDI=16) or with suicidal risk (item G BDI > 0).
- •6. Any significant serious abnormality of the cardiovascular illness e.g. recent myocardial infarction, angina, hypertension or dysrhythmias (within the prior 6 months), Electrocardiogram Bazett’s corrected QT interval (QT x root from [HR/60]) strickly higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse.
- •7. Patients with Severe hepatic Impairment (e.g. prothrombin ratio < 50% or factor V < 50% for patients receiving anti-vitamin K medication) or with Severe Renal Impairment (e.g. serum creatine greater than 2.0 mg/dl), or with any other significant abnormality in the physical examination or clinical laboratory results.
- •8. Psychiatric and neurological disorders, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator’s opinion would preclude the patient’s participation and completion of this trial or comprise reliable representation of subjective symptoms.
- •9. Prior severe adverse reactions to CNS stimulants.
- •10. Known hypersensitivity to the tested treatment including active substance and inactive excipients.
- •11. Other active clinically significant illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study objectives.
- •12. Any patients presenting congenital galactosemia, glucose-galactose malabsorption or lactase deficiency due to the presence of lactose in investigational treatments.
研究者
相似试验
进行中（未招募）
不适用
Prospective, randomized, double-blind study, parallel-group, multi-center trial assessing the effects of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy. - Harmony IIcataplexy treatment in patients with narcolepsyMedDRA version: 9.1Level: LLTClassification code 10028713Term: NarcolepsyMedDRA version: 9.1Level: LLTClassification code 10048322Term: Narcolepsy aggravatedMedDRA version: 9.1Level: LLTClassification code 10021235Term: Idiopathic narcolepsyMedDRA version: 9.1Level: LLTClassification code 10007737Term: CataplexyMedDRA version: 9.1Level: LLTClassification code 10048323Term: Cataplexy aggravatedEUCTR2008-007845-29-NLBioprojet40
已完成
3 期
Prospective, randomized, double-blind study, parallel-group, multi-center trial assessing the effects of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy.abrupt muscular weakness and EDS epinessCataplexy and narcolepsy10040998NL-OMON33083Bioprojet2
已完成
不适用
A clinical trial to compare the effects of two anaesthetic drugs- desflurane and isoflurane in patients undergoing elective neurosurgery.CTRI/2010/091/000616Dr Aparanjit Paul60
已完成
不适用
Single-site robotic cholecystectomy versus four-port laparoscopic cholecystectomy in patients with cholelithiasis or gallbladder polyps: a prospective, randomized, double blind study.ACTRN12614000119695Andrea Pietrabissa60
已完成
不适用
A prospective, randomized, double blind study comparing lutein to placebo for reducing occurrence and severity of retinopathy of prematurity, and evaluating antioxidative power and central visual function.Preterm infantsJPRN-UMIN000007041Catholic University of the Sacred Heart70