Trial Outcomes & Findings for Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance (NCT NCT00955253)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

5 days

Results posted on

2020-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	Guanfacine Then Placebo This group individuals are randomised to receive Guanfacine at the first treatment session and Placebo at the second treatment session.	Placebo Then Guanfacine This group individuals are randomised to receive Placebo at the first treatment session and Guanfacine at the second treatment session.
First Intervention (Day 2) STARTED	7	6
First Intervention (Day 2) COMPLETED	7	6
First Intervention (Day 2) NOT COMPLETED	0	0
Second Intervention (Day 4) STARTED	7	6
Second Intervention (Day 4) COMPLETED	7	6
Second Intervention (Day 4) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug and Placebo n=13 Participants 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: 2mg oral guanfacine (encapsulated) Placebo: placebo
Age, Continuous	63.2 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United Kingdom	13 Participants n=5 Participants
Behavioural Inattention Test Star Cancellation Score (Total targets found)	35.4 Number of targets found STANDARD_DEVIATION 15.9 • n=5 Participants
Mesulam Shape Cancellation Score (Total targets found)	25.6 Number of targets found STANDARD_DEVIATION 13.7 • n=5 Participants
Touchscreen Cancellation	28.4 Number of targets found STANDARD_DEVIATION 13.9 • n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: Baseline performance was determined for each patient by averaging scores on days 1, 3 and 5, as well as the preadministration sessions on days 2 and 4. Group averages and differences were computed between treatment type (baseline, guanfacine and placebo) across individuals.

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.

Outcome measures

Outcome measures
Measure	All Patients n=13 Participants All individuals received guanfacine and placebo in a crossover design.
Performance on Tests of Hemispatial Neglect and Sustained Attention Touchscreen Cancellation-Guanfacine	31.15 Number of targets found Standard Deviation 15.1
Performance on Tests of Hemispatial Neglect and Sustained Attention Touchscreen Cancellation-Placebo	26.15 Number of targets found Standard Deviation 14.29

SECONDARY outcome

Timeframe: 5 Days

Population: All patients were unable to carry out this task (9 hold PEG test of finger dexterity) because of the paralysis caused by their stroke.

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.

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Paresh Malhotra

Imperial College London

Phone: 0208 846 1234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place