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

Abbott

Status and phase: Completed; Phase 4

Conditions: Gait or Balance Disorder Problems

Treatments: Other: placebo; Drug: betahistine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01468285

S108.4.104

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects with gait or balance disorder problems
2. Male and female subjects aged on 40 years and above.
3. Absence of known contraindications for betahistine treatment.
4. Currently not on betahistine (of any formulation) treatment for at least 45 days prior to inclusion in the study.
5. Subject consuming caffeinated or alcoholic beverages should have stable consumption throughout the study period.

Exclusion criteria

1. History of discontinuation of betahistine treatment (of any formulation) in the past due to lack of efficacy or side effects.
2. Subjects treated with antihistamines and monoamine oxidase (MAO) inhibitors 30 days prior to inclusion in the study.
3. Subjects with hypersensitivity to the active substance or to any of the excipients of the drug.
4. Phaeochromocytoma
5. Porphyria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Treatment arm 1: betahistine dihydrochloride

Experimental group

Treatment:

Drug: betahistine dihydrochloride

Treatment arm 2: placebo

Placebo Comparator group

Treatment:

Other: placebo