The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow

Study Overview
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Brief Summary
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Betahistine may provide benefit by enhancement of Cerebral Blood Flow (CBF). This placebo-controlled pharmacodynamic treatment study will primarily explore the effect of betahistine on cerebral blood flow measured by dynamic contrast-enhanced MRI imaging, in a patient population with MRI evidence of cerebrovascular compromise. Also it will be measured if CBF changes correlate with gait and cognitive changes.

Official Title
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A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Effect of Betahistine on Cerebral Blood Flow and Gait in Subjects at Risk of Falling

Conditions
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Gait or Balance Disorder Problems

Intervention / Treatment
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* Drug: betahistine dihydrochloride
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with gait or balance disorder problems Male and female subjects aged on 40 years and above. Absence of known contraindications for betahistine treatment. Currently not on betahistine (of any formulation) treatment for at least 45 days prior to inclusion in the study. Subject consuming caffeinated or alcoholic beverages should have stable consumption throughout the study period. Exclusion Criteria: History of discontinuation of betahistine treatment (of any formulation) in the past due to lack of efficacy or side effects. Subjects treated with antihistamines and monoamine oxidase (MAO) inhibitors 30 days prior to inclusion in the study. Subjects with hypersensitivity to the active substance or to any of the excipients of the drug. Phaeochromocytoma Porphyria

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm 1: betahistine dihydrochloride<br> | Drug: betahistine dihydrochloride<br>* betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment<br>* Other names: Agiserc®;|
| Placebo Comparator: Treatment arm 2: placebo<br> | Other: placebo<br>* placebo tablets b.i.d., six weeks treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Blood Flow (CBF) | To explore the sustained effect of betahistine on the cerebral blood flow (CBF) in the whole brain. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional Cerebral Blood Flow (rCBF) | To explore the sustained effect of betahistine on the regional cerebral blood flow (rCBF) in pre-determined regions of interest. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interventional,placebo controlled