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OpenTrials
Completed

NCT Number: NCT01468285

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

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.

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Key information

Conditions

Gait or Balance Disorder Problems

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site Reference ID/Investigator# 63544, Singapore

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

betahistine dihydrochloride

Drug

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

Other names: Agiserc®

Placebo

Other

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

Primary outcomes

  1. Cerebral Blood Flow (CBF)

    Time frame: 6 weeks

    To explore the sustained effect of betahistine on the cerebral blood flow (CBF) in the whole brain.

Secondary outcomes

  1. Regional Cerebral Blood Flow (rCBF)

    Time frame: 6 weeks

    To explore the sustained effect of betahistine on the regional cerebral blood flow (rCBF) in pre-determined regions of interest.

Sponsors and collaborators

Lead sponsor

Abbott Products

Industry

Registry information

Official study title

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

Acronym: CBF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 9, 2011
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.