Gait or Balance Disorder ProblemsPhase 4CBFNCT01468285
The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow
A Phase 4 study testing betahistine dihydrochloride in people with Gait or Balance Disorder Problems, run by Abbott Products at 2 sites in Singapore.
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… Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Gait or Balance Disorder Problems
- What is being tested?
- betahistine dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesSingapore
- Study dates
- Feb 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Site Reference ID/Investigator# 63545
Singapore, 169608
Site Reference ID/Investigator# 63544
Singapore, 308433
About this study
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
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.
- Conditions
- Gait or Balance Disorder Problems
- Being tested
- betahistine dihydrochloride, placebo
- Keywords
- interventional,placebo controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
betahistine dihydrochlorideDrug
Also called Agiserc®
betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment
placeboOther
placebo tablets b.i.d., six weeks treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm 1: betahistine dihydrochloride | Experimental | Not described Receives: Drug: betahistine dihydrochloride |
| Treatment arm 2: placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow (CBF)
To explore the sustained effect of betahistine on the cerebral blood flow (CBF) in the whole brain.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait or Balance Disorder ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitri Kazei, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468285
- Sponsor's protocol ID
- S108.4.104
- Acronym
- CBF
- Status last verified
- Oct 2017
- First submitted
- 7 Nov 2011
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01468285
- Acronym / sponsor ID
- CBF / S108.4.104
- Conditions
- Gait or Balance Disorder Problems
- Keywords
- interventional,placebo controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Abbott ProductsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1: betahistine dihydrochloride | Experimental | Drug: betahistine dihydrochloride |
| Treatment arm 2: placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| betahistine dihydrochlorideAlso: Agiserc®betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment | Drug | Treatment arm 1: betahistine dihydrochloride |
| placeboplacebo tablets b.i.d., six weeks treatment | Other | Treatment arm 2: placebo |
Primary outcome
Cerebral Blood Flow (CBF)
Time frame: 6 weeks
To explore the sustained effect of betahistine on the cerebral blood flow (CBF) in the whole brain.
1 secondary outcome
Regional Cerebral Blood Flow (rCBF)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Kazei, MD study director
Abbott
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing betahistine dihydrochloride in people with Gait or Balance Disorder Problems, run by Abbott Products at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Blood Flow (CBF) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.