Status:
COMPLETED
The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow
Lead Sponsor:
Abbott Products
Conditions:
Gait or Balance Disorder Problems
Eligibility:
All Genders
40-99 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01468285
Start Date
February 1 2012
End Date
April 1 2013
Last Update
October 26 2017
Active Locations (2)
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1
Site Reference ID/Investigator# 63545
Singapore, Singapore, 169608
2
Site Reference ID/Investigator# 63544
Singapore, Singapore, 308433