A phase II, randomized, double-blind, parallel groups study to assess the efficacy and safety of Nimodipine 20 mg + Betahistine 16 mg versus Placebo + Betahistine 16 mg in the treatment of vertigo

MDM S.p.A.0 个研究点开始时间: 2014年1月9日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•1. Age > 20 years (both gender)
•2. Patients with a complaint of vertigo attacks lasting at least 3 months
•3. Baseline total DHI score > 40
•4. Negative pregnancy test for women of childbearing potential (to be performed at Visit 1) and use of an acceptable mean of contraception in the previous 2 months and for whole duration of the study
•5. Signed Informed Consent
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1. Cerebellopontine lesions, multiple sclerosis, acustic neuroma or other CNS tumor, as demonstrated by a CT scan or NMR (will be valid a CT scan/NMR performed within 3 months from visit 1)
•2. Patients treated with calcium channel blockers, antihistamines, rifampicin, phenobarbital, phenytoin or carbamazepine
•3. Known allergies, hypersensitivity, or intolerance to nimodipine or betahistine or any excipients used in their manufacture
•4. Patient with clinical gastrointestinal malabsorption
•5. Patients with blood pressure <100/70 mmHg
•6. Patients with bronchial asthma
•7. Patients with a history of peptic ulcer
•8. Patients with urticaria, exanthema or allergic rhinitis
•9. Patients with phaeochromocytoma
•10. Pregnancy, breast feeding
•11. Use of vestibular suppressants drugs 7 days prior to study treatment start
•12. ALT > 1.5 upper normal limit (UNL), AST > 1.5 UNL, alkaline phosphatase > 1.5 UNL, total bilirubin > 2 UNL, creatinine > 1.5 UNL
•13. Treatment with another investigational agent within the last 30 days
•14. Subjects with evidence of clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator's opinion, preclude entry into the study
•15. Known or suspected history of alcohol or drug abuse based on medical history, physical examination, or the Investigator's clinical judgment

发起方

MDM S.p.A.