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

NCT ID: NCT01468285

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gait or Balance Disorder Problems

Keywords

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interventional,placebo controlled

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment arm 1: betahistine dihydrochloride

Group Type EXPERIMENTAL

betahistine dihydrochloride

Intervention Type DRUG

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

Treatment arm 2: placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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betahistine dihydrochloride

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

Intervention Type DRUG

placebo

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

Intervention Type OTHER

Other Intervention Names

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Agiserc®

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dmitri Kazei, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 63545

Singapore, , Singapore

Site Status

Site Reference ID/Investigator# 63544

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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S108.4.104

Identifier Type: -

Identifier Source: org_study_id