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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468285
First Posted: November 9, 2011
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott ( Abbott Products )
  Purpose
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.

Condition Intervention Phase
Gait or Balance Disorder Problems Drug: betahistine dihydrochloride Other: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Abbott ( Abbott Products ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 27
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 1: betahistine dihydrochloride Drug: betahistine dihydrochloride
betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment
Other Name: Agiserc®
Placebo Comparator: Treatment arm 2: placebo Other: placebo
placebo tablets b.i.d., six weeks treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468285


Locations
Singapore
Site Reference ID/Investigator# 63545
Singapore, Singapore, 169608
Site Reference ID/Investigator# 63544
Singapore, Singapore, 308433
Sponsors and Collaborators
Abbott Products
Investigators
Study Director: Dmitri Kazei, MD Abbott
  More Information

Responsible Party: Abbott Products
ClinicalTrials.gov Identifier: NCT01468285     History of Changes
Other Study ID Numbers: S108.4.104
First Submitted: November 7, 2011
First Posted: November 9, 2011
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Abbott ( Abbott Products ):
interventional,placebo controlled

Additional relevant MeSH terms:
Betahistine
Vasodilator Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs