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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Imperial College London.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention Phase
Stroke
Hemispatial Neglect
Drug: Guanfacine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Performance on tests of hemispatial neglect and sustained attention [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Performance on Motor Tasks [ Time Frame: 5 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955253

Locations
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W6 8RF
Contact: Paresh Malhotra, PhD MRCCP    442088467286    p.malhotra@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Wellcome Trust
Investigators
Principal Investigator: Paresh A Malhotra, PhD MRCP Imperial College London
Principal Investigator: Masud Husain, DPhil FRCP University College, London
  More Information

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00955253     History of Changes
Other Study ID Numbers: CRO1234, NRES09/H0711/5, MHRA2008-001160-36
Study First Received: August 7, 2009
Last Updated: April 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Neglect
Attention
Vigilance
Stroke
Hemineglect
Unilateral Neglect
Spatial Neglect

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Guanfacine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014