E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047340 |
E.1.2 | Term | Vertigo |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
Valutare l'efficacia di Nimodipina 20 mg + Betaistina 16 mg (b.i.d) nel trattamento della vertigine, rispetto a Betaistina 16 mg (b.i.d), misurata tramite la Dizziness Handicap Inventory (DHI) dopo 4 settimane di trattamento |
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E.2.2 | Secondary objectives of the trial |
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
2. To evaluate the quality of life in patients with vertigo, using the SF-12 questionnaire
▪ Safety Objectives
1. To investigate the safety and tolerability of Nimodipine 20 mg + Betahistine 16 mg (b.i.d.) |
1. Valutare la disabilità auto-percepita dovuta a vertigine tramite il cambiamento del Mean Vertigo Score (MVS), calcolato come somma dei valori relativi a vertigini, capogiri e instabilità diviso per tre
2. Valutare la qualità della vita in pazienti con vertigine utilizzando il questionario SF-12
▪ Obiettivi di sicurezza (Safety)
1. Studiare la sicurezza (safety) e la tollerabilità di Nimodipina 20 mg + Betaistina 16 mg (b.i.d) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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 |
1. Età > 20 anni (entrambi i sessi)
2. Pazienti che presentano attacchi vertiginosi della durata di almeno 3 mesi
3. Punteggio totale DHI > 40 alla baseline
4. Test di gravidanza negativo per le donne in età fertile (da effettuare alla Visita 1) e l'uso di un mezzo accettabile di contraccezione nel corso degli ultimi 2 mesi e per tutta la durata dello studio
5. Consenso Informato firmato |
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E.4 | Principal exclusion criteria |
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 |
1. Lesione ponto-cerebellare, sclerosi multipla, neurinoma acustico o altri tumori del SNC, come dimostrato da TAC o RMN (sarà valida una TAC/RMN eseguita entro 3 mesi dalla visita 1)
2. Pazienti trattati con calcio-antagonisti, antistaminici, rifampicina, fenobarbital, fenitoina or carbamazepina
3. Ipersensibilità nota al principio attivo (nimodipina, betaistina) o ad uno qualsiasi degli eccipienti
4. Pazienti affetti da malassorbimento
5. Pazienti con valori di pressione arteriosa <100/70 mmHg
6. Pazienti affetti da asma bronchiale
7. Pazienti con storia di ulcere peptiche
8. Pazienti affetti da orticaria, esantema, rinite allergica
9. Pazienti con feocromocitoma
10. Gravidanza, allatamento
11. Uso di farmaci vestibolo-soppressori 7 giorni prima dell'inizio del trattamento
12. ALT > 1.5 limite superiore della norma (UNL), AST > 1.5 UNL, fosfatasi alcalina > 1.5 UNL, bilirubina totale > 2 UNL, creatinina > 1.5 UNL
13. Pazienti che abbiano preso parte ad altre sperimentazioni cliniche nei 30 giorni precedenti
14. Soggetti che presentano condizioni cliniche instabili basate sull'anamnesi e sull'esame fisico e che secondo il giudizio dello sperimentatore precludono la partecipazione allo studio
15. Nota o sospetta storia di abuso di alcol o di droghe basata sull'anamnesi, sull'esame fisico o sulla valutazione clinica dello sperimentatore |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of DHI after 4 weeks of treatment |
Riduzione della DHI dopo 4 settimane di trattamento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 4 weeks of treatment |
Dopo 4 settimane di trattamento |
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E.5.2 | Secondary end point(s) |
1. Reduction of MVS after 4 weeks of treatment
2. Change in SF-12 scores after 4 weeks of treatment
3. Percentage of patients presenting adverse events
4. Number of patients presenting laboratorial changes |
1. Riduzione della MVS dopo 4 settimane di trattamento
2. Variazione punteggio della SF-12 dopo 4 settimane di trattamento
3. Percentuale di pazienti che presentano eventi avversi
4. Numero di pazienti che presentano variazioni significative degli esami di laboratorio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. After 4 weeks of treatment
2. After 4 weeks of treatment
3. During all the study
4. After 4 weeks of treatment |
1. Dopo 4 settimane di trattamento
2. Dopo 4 settimane di trattamento
3. Durante tutta la durata dello studio
4. Dopo 4 settimane di trattamento |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |