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
- Conditions
- VertigoMedDRA version: 16.1Level: PTClassification code 10047340Term: VertigoSystem Organ Class: 10013993 - Ear and labyrinth disordersTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2013-005122-33-IT
- Lead Sponsor
- MDM S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Nimodipine 20 mg + Betahistine 16 mg (b.i.d) for the treatment of vertigo, compared to Betahistine 16 mg (b.i.d), as assessed by the Dizziness Handicap Inventory (DHI) after 4 weeks of treatment;Primary end point(s): Reduction of DHI after 4 weeks of treatment;Timepoint(s) of evaluation of this end point: After 4 weeks of treatment;Secondary Objective: 1. To evaluate the self-perceived vertigo disability as assesed by the change of Mean Vertigo Score (MVS), based on the sum of vertigo, dizziness, unsteadiness divided by three<br>2. To evaluate the quality of life in patients with vertigo, using the SF-12 questionnaire<br><br>? Safety Objectives<br>1. To investigate the safety and tolerability of Nimodipine 20 mg + Betahistine 16 mg (b.i.d.)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Reduction of MVS after 4 weeks of treatment<br>2. Change in SF-12 scores after 4 weeks of treatment<br>3. Percentage of patients presenting adverse events<br>4. Number of patients presenting laboratorial changes;Timepoint(s) of evaluation of this end point: 1. After 4 weeks of treatment<br>2. After 4 weeks of treatment<br>3. During all the study<br>4. After 4 weeks of treatment