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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT01468285
First received: November 7, 2011
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Gait or Balance Disorder Problems
Drug: betahistine dihydrochloride
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Cerebral Blood Flow (CBF) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To explore the sustained effect of betahistine on the cerebral blood flow (CBF) in the whole brain.


Secondary Outcome Measures:
  • Regional Cerebral Blood Flow (rCBF) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To explore the sustained effect of betahistine on the regional cerebral blood flow (rCBF) in pre-determined regions of interest.


Enrollment: 27
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 1: betahistine dihydrochloride Drug: betahistine dihydrochloride
betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment
Other Name: Agiserc®
Placebo Comparator: Treatment arm 2: placebo Other: placebo
placebo tablets b.i.d., six weeks treatment

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468285

Locations
Singapore
Site Reference ID/Investigator# 63544
Singapore, Singapore, 308433
Site Reference ID/Investigator# 63545
Singapore, Singapore, 169608
Sponsors and Collaborators
Abbott Products
Investigators
Study Director: Dmitri Kazei, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT01468285     History of Changes
Other Study ID Numbers: S108.4.104
Study First Received: November 7, 2011
Last Updated: May 29, 2013
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Abbott:
interventional,placebo controlled

Additional relevant MeSH terms:
Betahistine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014