Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance (GASNIV)
Recruitment status was Recruiting
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.
|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|
- Performance on tests of hemispatial neglect and sustained attention [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Performance on Motor Tasks [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
|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)|
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.
2mg oral guanfacine (encapsulated)
Other Name: EstulicDrug: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955253
|Imperial College Healthcare NHS Trust||Recruiting|
|London, United Kingdom, W6 8RF|
|Contact: Paresh Malhotra, PhD MRCCP 442088467286 email@example.com|
|Principal Investigator:||Paresh A Malhotra, PhD MRCP||Imperial College London|
|Principal Investigator:||Masud Husain, DPhil FRCP||University College, London|