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

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. Identifier: NCT01468285
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
Abbott ( Abbott Products )

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01468285

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

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

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

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