Status:

COMPLETED

Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance

Lead Sponsor:

Imperial College London

Collaborating Sponsors:

Wellcome Trust

Conditions:

Stroke

Hemispatial Neglect

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

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 stud...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 28 2014

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT00955253

Start Date

April 1 2010

End Date

March 28 2014

Last Update

January 21 2020

Active Locations (1)

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1

Imperial College Healthcare NHS Trust

London, United Kingdom, W6 8RF