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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002474-52 | EudraCT Number |
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Treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance).
This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Nasal spray solution without active ingredient |
|
| 1 mg AM-125 | Experimental | Nasal spray solution with 5 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 3 mg betahistine dihydrochloride. |
|
| 10 mg AM-125 | Experimental | Nasal spray solution with 50 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 30 mg betahistine dihydrochloride. |
|
| 20 mg AM-125 | Experimental | Nasal spray solution with 100 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 60 mg betahistine dihydrochloride. |
|
| Oral 16 mg betahistine | Experimental | Tablets containing betahistine dihydrochloride. Administered three times daily as 1 tablet per time. Total daily dose is 48 mg oral betahistine dihydrochloride. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Drug | Drug | Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of time standing on foam (eyes closed) | Day 3 to Day 14 | |
| Improvement in tandem Romberg test (eyes closed) | Participants will be asked to stand straight in tandem stand (heel of one foot touching the toes of the other foot) and duration in this position will be measured. | Day 3 to Day 14 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHP Clairval | Marseille | France |
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| Label | URL |
|---|---|
| Link to Result entry in clinicaltrialsregister.eu | View source |
| Link to peer-reviewed publication of study | View source |
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| ID | Term |
|---|---|
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000281 | Administration, Intranasal |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D058956 | Administration, Mucosal |
| D000287 | Administration, Topical |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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For intranasal subjects, allocation is blinded. The oral arm is an open-label arm.
| Oral Tablet | Drug | Oral dosing with tablets 3 times a day |
|
| Intranasal Placebo | Other | Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 | Therapeutics |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |