Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance (GASNIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00955253
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : June 4, 2015
Wellcome Trust
Information provided by (Responsible Party):
Imperial College London

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Stroke Hemispatial Neglect Drug: Guanfacine Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Trial of Guanfacine, an Alpha 2 Adrenergic Agonist, for Spatial Neglect and Impaired Vigilance Following Stroke and Focal Brain Damage
Study Start Date : April 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Drug and Placebo
All patients will receive a single dose of drug and a single dose of placebo on separate days of the trial period. The order in which they receive these will be randomized.
Drug: Guanfacine
2mg oral guanfacine (encapsulated)
Other Name: Estulic

Drug: Placebo

Primary Outcome Measures :
  1. Performance on tests of hemispatial neglect and sustained attention [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Performance on Motor Tasks [ Time Frame: 5 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00955253

United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Wellcome Trust
Principal Investigator: Paresh A Malhotra, PhD MRCP Imperial College London
Principal Investigator: Masud Husain, DPhil FRCP University College, London

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Imperial College London Identifier: NCT00955253     History of Changes
Other Study ID Numbers: CRO1234
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2011

Keywords provided by Imperial College London:
Unilateral Neglect
Spatial Neglect

Additional relevant MeSH terms:
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs