EUCTR2016-000316-15-PL进行中（未招募）1 期
Clinical Trial to Explore Treatment Effects of Ginkgo biloba Extract EGb 761® in Patients with Different Types of Vertigo and Effect Modification by Type of Vertigo, Chronicity and Concomitant Pathologies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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
- •Inclusion criteria
- •1. Outpatients of both sexes, at least 18 years old.
- •2. Vertigo syndrome
- •a. diagnosed and specified by medical history and physical examination, Rombergtest, Unterberger stepping test, nystagmus testing with (alternatively by VNG) andwithout Frenzel glasses, and the following diagnostic tests which may have beenperformed up to 3 months before Baseline Visit: ENG or VNG including caloric testing, vHIT, VEMPs, Dix-Hallpike test (only to be performed if necessary to exclude BPPV), ECG;
- •b. excluding BPPV, Ménière's disease, vestibular migraine, somatoform phobic
- •vertigo, acute vestibular neuritis within the first two weeks of onset, acute central or peripheral vertigo within the first two weeks of onset;
- •c. duration of at least 2 weeks.
- •3. Score > 25 in the Dizziness Handicap Inventory.
- •4. Written informed consent to participate in the clinical trial, to trial-related treatment and to data recording in accordance with applicable laws.
- •Note: The gaze test and positional test may alternatively be performed with Frenzelglasses instead of ENG / VNG.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Participation in another experimental drug trial at the same time or within the past 4 weeks before Baseline Visit.
- •2. Vertigo for which other treatments are recommended by current guidelines or expert consensus: BPPV, Ménière's disease, vestibular migraine, somatoform phobic vertigo, acute vestibular neuritis within the first two weeks of onset, acute central or peripheral vertigo within the first two weeks of onset.
- •3. Any other drug treatments for vertigo taken currently or within 2 weeks before Baseline Visit.
- •4. Gingko biloba preparation for any reason taken currently or within 4 weeks before Baseline Visit.
- •5. Ongoing psychiatric disorder, such as major depression, generalized anxiety disorder, schizophrenia, etc.
- •Of note: Symptoms of depression or anxiety or other behavioral or psychological symptoms at sub-syndromal level and not requiring treatment with psychotropic drugs are permitted.
- •6. Ongoing severe cardiac or circulatory disorder
- •a. severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
- •b. decompensated congestive heart failure (NYHA stage IV)
- •c. uncontrolled hypertension with systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 115 mmHg
- •d. clinically significant cardiac arrhythmias (Lown classes IVb and V, bifascicular bundle branch block).
- •7. Severe renal or hepatic dysfunction (defined by serum creatinine or serum ASAT, ALAT or gamma-GT above 3 times the upper limit of the reference range in the anamnesis).
- •8. Ongoing uncontrolled endocrine or hematological disorder.
- •9. Intake of drugs not permitted during participation in the trial, in particular, psychoactive drugs, systemic acting perfusion-enhancing drugs, cognition enhancing drugs, systemic acting anti-cholinergic drugs, regular use of anticoagulants (platelet aggregation inhibitors permitted) during the 2 weeks prior to Baseline Visit.
- •10. Ongoing hemorrhagic diathesis or coagulation disorder.
- •11. Seizure within 2 years prior to Baseline Visit or regular use anticonvulsive drugs.
- •12. Active malignant disease (exception: prostate cancer which does not require other than hormone treatment within the next 6 months).
- •13. Known hypersensitivity to Ginkgo biloba extract or to excipients contained in the tablets.
- •14. Active peptic ulcer disease or any gastrointestinal disease with potential impairment of the absorption of orally applied drugs (e.g. Billroth I/II, Crohn's disease, ulcerative colitis, any kind of enterectomy).
- •15. Female patients of childbearing potential without safe contraception (any form of hormonal contraception, intrauterine devices, sexual abstinence and partner sterilization are considered sufficiently safe when used consistently and correctly; child-bearing potential can be denied in case of postmenopausal state for at least 2 years, hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- •16. Planned surgical intervention requiring hospitalization during the clinical trial.
- •17. Previous inclusion in the present clinical trial.
- •18. Incapability of understanding nature, meaning and consequences of the clinical trial.
- •19. Patient unable to read and / or write.
- •20. Patients in custody by juridical or official order.
- •21. Patients, who are members of the staff of the trial center, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator.
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