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

October 25, 2017 updated by: Abbott Products

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Site Reference ID/Investigator# 63545
      • Singapore, Singapore, 308433
        • Site Reference ID/Investigator# 63544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm 1: betahistine dihydrochloride
Drug: betahistine dihydrochloride
betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment
Other Names:
  • Agiserc®
Placebo Comparator: Treatment arm 2: placebo
Other: placebo
placebo tablets b.i.d., six weeks treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Products

Investigators

  • Study Director: Dmitri Kazei, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S108.4.104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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