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

This study is currently recruiting participants.
Verified June 2011 by Imperial College London
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00955253
First received: August 7, 2009
Last updated: April 5, 2013
Last verified: June 2011
History of Changes

August 7, 2009
April 5, 2013
April 2010
October 2013   (final data collection date for primary outcome measure)
Performance on tests of hemispatial neglect and sustained attention [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00955253 on ClinicalTrials.gov Archive Site
Performance on Motor Tasks [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Stroke
  • Hemispatial Neglect
  • Drug: Guanfacine
    2mg oral guanfacine (encapsulated)
    Other Name: Estulic
  • Drug: Placebo
    placebo
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.
Interventions:
  • Drug: Guanfacine
  • Drug: Placebo
Malhotra PA, Parton AD, Greenwood R, Husain M. Noradrenergic modulation of space exploration in visual neglect. Ann Neurol. 2006 Jan;59(1):186-90.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United Kingdom
 
NCT00955253
CRO1234, NRES09/H0711/5, MHRA2008-001160-36
Yes
Imperial College London
Imperial College London
Wellcome Trust
Principal Investigator: Paresh A Malhotra, PhD MRCP Imperial College London
Principal Investigator: Masud Husain, DPhil FRCP University College, London
Imperial College London
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP