StrokePhase 2GASNIVNCT00955253
Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance
A Phase 2 study testing Guanfacine in people with Stroke and Hemispatial Neglect, run by Imperial College London at 1 site in United Kingdom.
Trial summary
To find out if spatial neglect following stroke and brain injury can be reduced using guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous pilot study (Malhotra et al, 2006). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemispatial Neglect
- What is being tested?
- Guanfacine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to 28 Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or more
- Greater than 2 weeks following stroke
- Ability to give consent
- Evidence of robust Visual Neglect when tested twice with cancellation tasks.
Who cannot join
- Less than 2 weeks following stroke
- Concomitant illness that may affect interpretation of any findings
- Labile blood pressure following stroke
- Systolic BP less than 100 mmHg and / or diastolic less than 70 mmHg
- New antihypertensive medication started within last 3 weeks
- Patients with hepatic or renal dysfunction
Show all 14Show fewer
- Patients receiving other medications known to potentiate guanfacine's antihypertensive and hypotensive effects or cause torsade de pointes, specifically antipsychotics (including sultopride, chlorpromazine, thioridazine, amisulpiride, sulpiride, haloperidol), and moxifloxacin, baclofen, verapamil, quinidine, hydroquinidine, dispyramide, amiodarone, dofetilide, ibutilide, sotalol, pimozide, bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, vincamine, alfuzosin, prazosin, terazosin, tamsulosin, amifostine
- Patients with diagnosis of brain tumour
- Patients with weight less than 55kg
- Patients who are pregnant
- Mothers who are breast feeding
- Patients with severe coronary insufficiency or myocardial infarction in previous 6 months
- Cognitive impairment, dysphasia or dementia that prevents patient from giving informed consent
- Severe mental impairment or physical handicap following stroke that prevents patients from giving consent or performing basic (standard clinical) tests for neglect
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W6 8RF
About this study
Official title: A Trial of Guanfacine, an Alpha 2 Adrenergic Agonist, for Spatial Neglect and Impaired Vigilance Following Stroke and Focal Brain Damage
To find out if spatial neglect following stroke and brain injury can be reduced using guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous pilot study (Malhotra et al, 2006). In this trial, the effects of guanfacine will be examined in a larger number of patients, and there will also be a systematic assessment of whether the drug is only effective in patients with particular patterns of brain damage.
Read the detailed description
The current study has a double-blind crossover design where patients will receive a single 2mg dose of oral guanfacine and a single dose of placebo. They will receive one of these on Day 2 of the study period and the other on Day 4.
They will be tested daily on Days 1 to 5 so that any test repetition or long-term drug effects can be gauged.
On days 2 and 4 they will be tested twice-once prior to drug/placebo administration and again 90 minutes after drug/placebo administration.
Tests will include standard pen-and-paper tasks for neglect as well as computerised tests of sustained attention and visual exploration. In our published pilot study (Malhotra et al, 2006) there was a suggestion that patients without damage to frontal cortex were more likely to respond to guanfacine. In the current study we intend to test 10 patients with and 10 patients without frontal damage in order to test this further.
- Conditions
- Stroke, Hemispatial Neglect
- Being tested
- Guanfacine, Placebo
- Keywords
- Neglect, Attention, Vigilance, Stroke, Hemineglect, Unilateral Neglect, Spatial Neglect
- Medical subject headings
- Stroke, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuanfacineDrug
Also called Estulic
2mg oral guanfacine (encapsulated)
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Guanfacine (Day 2) then Placebo (Day 4) | Experimental | All patients received a single dose of guanfacine on Day 2 and a single dose of placebo on Day 4. Receives: Drug: Guanfacine; Drug: Placebo |
| Placebo (Day 2) then Guanfacine (Day 4) | Experimental | All patients received a single dose of placebo on Day 2 and a single dose of guanfacine on Day 4. Receives: Drug: Guanfacine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on Tests of Hemispatial Neglect and Sustained Attention
Touchscreen Cancellation: This is a computerised scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation").The maximum number of targets that can be found is 64 (Therefore minimum score =0, maximum = 64), which represents normal performance.
Measured: 5 days
Secondary outcomes (1)
Performance on Motor Tasks
Time taken to take pegs from a container and place them into holes on a board, and then remove these pegs and replace them in the container.
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startApr 2010
- Primary completion28 Mar 2014
- Study completion28 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients were tested on five consecutive days. On days 1, 3 and 5, they were tested on a task battery. On day 2, individuals received active drug or placebo, and on day 4 they received placebo if they had previously received active drug and vice versa. The order of administration of guanfacine and placebo was counterbalanced across patients, according to a pregenerated randomisation scheme. The clinician who administered the drugs and the tests was blind to the randomisation and the drug. The analyses presented here were performed by a different researcher, only after all data were collected. On both treatment days, patients were tested on the task battery twice: once immediately before guanfacine/placebo administration and once 2 hours after.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Paresh A Malhotra, PhD MRCP, Principal investigator, Imperial College LondonMasud Husain, DPhil FRCP, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955253
- Sponsor's protocol ID
- CRO1234
- Other IDs
- NRES09/H0711/5, 2008-001160-36, 2008
- Acronym
- GASNIV
- Status last verified
- Jan 2020
- First submitted
- 7 Aug 2009
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malhotra PA, Parton AD, Greenwood R, Husain M. Noradrenergic modulation of space exploration in visual neglect. Ann Neurol. 2006 Jan;59(1):186-90. doi: 10.1002/ana.20701.
PubMed 16261567Dalmaijer ES, Li KMS, Gorgoraptis N, Leff AP, Cohen DL, Parton AD, Husain M, Malhotra PA. Randomised, double-blind, placebo-controlled crossover study of single-dose guanfacine in unilateral neglect following stroke. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):593-598. doi: 10.1136/jnnp-2017-317338. Epub 2018 Feb 7.
PubMed 29436486
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Guanfacine, an Alpha 2 Adrenergic Agonist, for Spatial Neglect and Impaired Vigilance Following Stroke and Focal Brain Damage
- ClinicalTrials.gov ID
- NCT00955253
- Acronym / sponsor ID
- GASNIV / CRO1234
- Conditions
- Stroke, Hemispatial Neglect
- Keywords
- Neglect, Attention, Vigilance, Stroke, Hemineglect, Unilateral Neglect, Spatial Neglect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Apr 2010 (actual)
- Primary completion
- 28 Mar 2014 (actual)
- Study completion
- 28 Mar 2014 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out if spatial neglect following stroke and brain injury can be reduced using guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous pilot study (Malhotra et al, 2006). In this trial, the effects of guanfacine will be examined in a larger number of patients, and there will also be a systematic assessment of whether the drug is only effective in patients with particular patterns of brain damage.
Detailed description
The current study has a double-blind crossover design where patients will receive a single 2mg dose of oral guanfacine and a single dose of placebo. They will receive one of these on Day 2 of the study period and the other on Day 4.
They will be tested daily on Days 1 to 5 so that any test repetition or long-term drug effects can be gauged.
On days 2 and 4 they will be tested twice-once prior to drug/placebo administration and again 90 minutes after drug/placebo administration.
Tests will include standard pen-and-paper tasks for neglect as well as computerised tests of sustained attention and visual exploration. In our published pilot study (Malhotra et al, 2006) there was a suggestion that patients without damage to frontal cortex were more likely to respond to guanfacine. In the current study we intend to test 10 patients with and 10 patients without frontal damage in order to test this further.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients were tested on five consecutive days. On days 1, 3 and 5, they were tested on a task battery. On day 2, individuals received active drug or placebo, and on day 4 they received placebo if they had previously received active drug and vice versa. The order of administration of guanfacine and placebo was counterbalanced across patients, according to a pregenerated randomisation scheme. The clinician who administered the drugs and the tests was blind to the randomisation and the drug. The analyses presented here were performed by a different researcher, only after all data were collected. On both treatment days, patients were tested on the task battery twice: once immediately before guanfacine/placebo administration and once 2 hours after.
| Arm | Type | Receives |
|---|---|---|
| Guanfacine (Day 2) then Placebo (Day 4) | Experimental | Drug: Guanfacine, Drug: PlaceboAll patients received a single dose of guanfacine on Day 2 and a single dose of placebo on Day 4. |
| Placebo (Day 2) then Guanfacine (Day 4) | Experimental | Drug: Guanfacine, Drug: PlaceboAll patients received a single dose of placebo on Day 2 and a single dose of guanfacine on Day 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or more
- Greater than 2 weeks following stroke
- Ability to give consent
- Evidence of robust Visual Neglect when tested twice with cancellation tasks.
Key exclusion criteria (14 listed)
- Less than 2 weeks following stroke
- Concomitant illness that may affect interpretation of any findings
- Labile blood pressure following stroke
- Systolic BP less than 100 mmHg and / or diastolic less than 70 mmHg
- New antihypertensive medication started within last 3 weeks
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 |
|---|---|---|
| GuanfacineAlso: Estulic2mg oral guanfacine (encapsulated) | Drug | Guanfacine (Day 2) then Placebo (Day 4), Placebo (Day 2) then Guanfacine (Day 4) |
| Placeboplacebo | Drug | Guanfacine (Day 2) then Placebo (Day 4), Placebo (Day 2) then Guanfacine (Day 4) |
Primary outcome
Performance on Tests of Hemispatial Neglect and Sustained Attention
Time frame: 5 days
Touchscreen Cancellation: This is a computerised scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation").The maximum number of targets that can be found is 64 (Therefore minimum score =0, maximum = 64), which represents normal performance.
1 secondary outcome
Performance on Motor Tasks
Time frame: 5 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16261567Malhotra PA, Parton AD, Greenwood R, Husain M. Noradrenergic modulation of space exploration in visual neglect. Ann Neurol. 2006 Jan;59(1):186-90. doi: 10.1002/ana.20701.
- Results publication: PubMed 29436486Dalmaijer ES, Li KMS, Gorgoraptis N, Leff AP, Cohen DL, Parton AD, Husain M, Malhotra PA. Randomised, double-blind, placebo-controlled crossover study of single-dose guanfacine in unilateral neglect following stroke. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):593-598. doi: 10.1136/jnnp-2017-317338. Epub 2018 Feb 7.
- Individual participant dataSharing planned: No
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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.
Paresh A Malhotra, PhD MRCP principal investigator
Imperial College London
Masud Husain, DPhil FRCP principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Guanfacine in people with Stroke and Hemispatial Neglect, run by Imperial College London at 1 site in United Kingdom.
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 4 inclusion and 14 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Performance on Tests of Hemispatial Neglect and Sustained Attention (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955253, which also lists 2 linked publications.
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 21 Jan 2020.