A trial of Guanfacine, an alpha 2 adrenergic agonist, for Spatial Neglect and Impaired Vigilance following Stroke and Focal Brain Damage - Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance

Phase 1

• Conditions: Spatial Neglect following Hemispheric stroke and focal brain injury; MedDRA version: 14.0 Level: LLT Classification code 10050400 Term: Vigilance decreased System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0 Level: PT Classification code 10029289 Term: Neurologic neglect syndrome System Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2008-001160-36-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-16
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

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 and line bisection. Specifically, this includes:
Overall score on cancellation tasks (Mesulam shape cancellation or BIT star cancellation) less then 75% total (with omissions on the left being 5 or more than omissions on the right)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 2 weeks
•Patients with hepatic or renal dysfunction
Patients on neuroleptic medication
•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 within the 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified