Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-03-28

Brief Summary

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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.

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Detailed Description

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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

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Stroke Hemispatial Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Guanfacine (Day 2) then Placebo (Day 4)

All patients received a single dose of guanfacine on Day 2 and a single dose of placebo on Day 4.

Group Type EXPERIMENTAL

Guanfacine

Intervention Type DRUG

2mg oral guanfacine (encapsulated)

Placebo

Intervention Type DRUG

placebo

Placebo (Day 2) then Guanfacine (Day 4)

All patients received a single dose of placebo on Day 2 and a single dose of guanfacine on Day 4.

Group Type EXPERIMENTAL

Guanfacine

Intervention Type DRUG

2mg oral guanfacine (encapsulated)

Placebo

Intervention Type DRUG

placebo

Interventions

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Guanfacine

2mg oral guanfacine (encapsulated)

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Estulic

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No