The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow
CBF
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
1 other identifier
interventional
27
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedOctober 26, 2017
October 1, 2017
1.2 years
November 7, 2011
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
Regional Cerebral Blood Flow (rCBF)
6 weeks
Study Arms (2)
Treatment arm 1: betahistine dihydrochloride
EXPERIMENTALTreatment arm 2: placebo
PLACEBO COMPARATORInterventions
betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment
Eligibility Criteria
You may qualify if:
- Subjects with gait or balance disorder problems
- Male and female subjects aged on 40 years and above.
- Absence of known contraindications for betahistine treatment.
- Subject consuming caffeinated or alcoholic beverages should have stable consumption throughout the study period.
You may not qualify if:
- History of discontinuation of betahistine treatment (of any formulation) in the past due to lack of efficacy or side effects.
- Subjects with hypersensitivity to the active substance or to any of the excipients of the drug.
- Phaeochromocytoma
- Porphyria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Productslead
Study Sites (2)
Site Reference ID/Investigator# 63545
Singapore, 169608, Singapore
Site Reference ID/Investigator# 63544
Singapore, 308433, Singapore
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dmitri Kazei, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
February 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
October 26, 2017
Record last verified: 2017-10