The CBF Study Evaluating the Effect of Betahistine on the... | NCT01468285

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

NCT01468285

Sponsor

Abbott Products

Status

Completed

Last Update Posted

Oct 26, 2017Actual

Enrollment

27Actual

Phase

Phase 4

Conditions

Gait or Balance Disorder Problems

Interventions

betahistine dihydrochloride
placebo

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Nov 7, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2017

Last Update Posted Date

Oct 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm 1: betahistine dihydrochloride	Experimental		Drug: betahistine dihydrochloride
Treatment arm 2: placebo	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
betahistine dihydrochloride	Drug	betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment	Treatment arm 1: betahistine dihydrochloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral Blood Flow (CBF)	To explore the sustained effect of betahistine on the cerebral blood flow (CBF) in the whole brain.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Regional Cerebral Blood Flow (rCBF)	To explore the sustained effect of betahistine on the regional cerebral blood flow (rCBF) in pre-determined regions of interest.	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dmitri Kazei, MD	Abbott	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 63545		Singapore		169608	Singapore
Site Reference ID/Investigator# 63544

Intervention Browse Module

MeSH Terms

ID	Term
D001621	Betahistine

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided