Phase 2
N=13
Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance
Stroke · Hemispatial Neglect
Bottom Line
View on ClinicalTrials.gov: NCT00955253 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Performance on Tests of Hemispatial Neglect and Sustained Attention — 31.15; 26.15 Number of targets found — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Guanfacine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance on Tests of Hemispatial Neglect and Sustained Attention |
31.15; 26.15 | 0.013 sig |
| SECONDARY Performance on Motor Tasks |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 or more
- Greater than 2 weeks following stroke
- Ability to give consent
- Evidence of robust Visual Neglect when tested twice with cancellation tasks.
Exclusion Criteria
- Less than 2 weeks following stroke
- Concomitant illness that may affect interpretation of any findings
- Labile blood pressure following stroke
- Systolic BP less than 100 mmHg and / or diastolic less than 70 mmHg
- New antihypertensive medication started within last 3 weeks
- Patients with hepatic or renal dysfunction
- Patients receiving other medications known to potentiate guanfacine's antihypertensive and hypotensive effects or cause torsade de pointes, specifically antipsychotics (including sultopride, chlorpromazine, thioridazine, amisulpiride, sulpiride, haloperidol), and moxifloxacin, baclofen, verapamil, quinidine, hydroquinidine, dispyramide, amiodarone, dofetilide, ibutilide, sotalol, pimozide, bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, vincamine, alfuzosin, prazosin, terazosin, tamsulosin, amifostine
- Patients with diagnosis of brain tumour
- Patients with weight less than 55kg
- Patients who are pregnant
- Mothers who are breast feeding
- Patients with severe coronary insufficiency or myocardial infarction in previous 6 months
- Cognitive impairment, dysphasia or dementia that prevents patient from giving informed consent
- Severe mental impairment or physical handicap following stroke that prevents patients from giving consent or performing basic (standard clinical) tests for neglect
Data sourced from ClinicalTrials.gov (NCT00955253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.