Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance "GASNIV"

Completed

Phase 2 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo
    ARM 1: Kind: Experimental
    Label: Drug and Placebo
    Description: 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.
  • Guanfacine Drug
    Other Names: Estulic
    Intervention Desc: 2mg oral guanfacine (encapsulated)
    ARM 1: Kind: Experimental
    Label: Drug and Placebo
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Performance on tests of hemispatial neglect and sustained attention 5 days No
Secondary Performance on Motor Tasks 5 Days No

Sponsors