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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01468285

Acronym

CBF

Enrollment

Registered

2011-11-09

Start date

2012-02-29

Completion date

2013-04-30

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait or Balance Disorder Problems

Keywords

interventional,placebo controlled

Brief summary

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.

Interventions

DRUGbetahistine dihydrochloride

betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment

OTHERplacebo

placebo tablets b.i.d., six weeks treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 99 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026