Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance (GASNIV)
|ClinicalTrials.gov Identifier: NCT00955253|
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemispatial Neglect||Drug: Guanfacine Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Trial of Guanfacine, an Alpha 2 Adrenergic Agonist, for Spatial Neglect and Impaired Vigilance Following Stroke and Focal Brain Damage|
|Study Start Date :||April 2010|
|Primary Completion Date :||August 2014|
|Study Completion Date :||August 2014|
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
- Performance on tests of hemispatial neglect and sustained attention [ Time Frame: 5 days ]
- Performance on Motor Tasks [ Time Frame: 5 Days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955253
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Paresh A Malhotra, PhD MRCP||Imperial College London|
|Principal Investigator:||Masud Husain, DPhil FRCP||University College, London|