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

Gait or Balance Disorder Problems Clinical Trial

— CBF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468285
• Other study ID #: S108.4.104
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2011
• Last updated: October 25, 2017
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2017
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait or Balance Disorder Problems

Intervention

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

Other:
• placebo
placebo tablets b.i.d., six weeks treatment

Locations

Country	Name	City	State
Singapore	Site Reference ID/Investigator# 63544	Singapore
Singapore	Site Reference ID/Investigator# 63545	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Products

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Blood Flow (CBF)	To explore the sustained effect of betahistine on the cerebral blood flow (CBF) in the whole brain.	6 weeks
Secondary	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