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

Phase 4

Completed

• Conditions: Gait or Balance Disorder Problems
• Interventions: Other: placebo; Drug: betahistine dihydrochloride

• Registration Number: NCT01468285
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Study Start: 2012-02
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm 2: placebo	placebo	-
Treatment arm 1: betahistine dihydrochloride	betahistine dihydrochloride	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Site Reference ID/Investigator# 63545; 🇸🇬 Singapore, Singapore

Site Reference ID/Investigator# 63544; 🇸🇬 Singapore, Singapore