A Phase 2 interventional study of Guanfacine and Placebo in Stroke and Hemispatial Neglect, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-21.
Sponsored by Imperial College London · Phase 2, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 13 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients received a single dose of guanfacine on Day 2 and a single dose of placebo on Day 4.
Drug: Guanfacine · Drug: Placebo
All patients received a single dose of placebo on Day 2 and a single dose of guanfacine on Day 4.
Drug: Guanfacine · Drug: Placebo
2mg oral guanfacine (encapsulated)
Also known as: Estulic
placebo
Performance on Tests of Hemispatial Neglect and Sustained Attention
Touchscreen Cancellation: This is a computerised scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation").The maximum number of targets that can be found is 64 (Therefore minimum score =0, maximum = 64), which represents normal performance.
Time frame: 5 days
Performance on Motor Tasks
Time taken to take pegs from a container and place them into holes on a board, and then remove these pegs and replace them in the container.
Time frame: 5 Days
| Milestone | Guanfacine Then Placebo | Placebo Then Guanfacine |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 6 |
| Not completed | 0 | 0 |
| Milestone | Guanfacine Then Placebo | Placebo Then Guanfacine |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 6 |
| Not completed | 0 | 0 |
Touchscreen Cancellation: This is a computerised scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation").The maximum number of targets that can be found is 64 (Therefore minimum score =0, maximum = 64), which represents normal performance.
| Number of targets found | All Patients |
|---|---|
| Touchscreen Cancellation-Guanfacine | 31.15 ± 15.1 |
| Touchscreen Cancellation-Placebo | 26.15 ± 14.29 |
Time taken to take pegs from a container and place them into holes on a board, and then remove these pegs and replace them in the container.
No measurements were reported for this outcome.
Collected over 5 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Drug and Placebo |
|---|---|
| Mean | 63.2 ± 10.3 |
| Sex: Female, Male(Participants) | Drug and Placebo |
|---|---|
| Female | 1 |
| Male | 12 |
| Region of Enrollment(Participants) | Drug and Placebo |
|---|---|
| United Kingdom | 13 |
| Behavioural Inattention Test Star Cancellation Score (Total targets found)(Number of targets found) | Drug and Placebo |
|---|---|
| Mean | 35.4 ± 15.9 |
| Mesulam Shape Cancellation Score (Total targets found)(Number of targets found) | Drug and Placebo |
|---|---|
| Mean | 25.6 ± 13.7 |
| Touchscreen Cancellation(Number of targets found) | Drug and Placebo |
|---|---|
| Mean | 28.4 ± 13.9 |
Plan to share: No
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Imperial College London