EUCTR2010-024048-14-GBActive, not recruitingPhase 1
A randomised-controlled trial of donepezil for motor recovery in acute stroke - Donepezil trial for motor recovery in acute stroke
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Imperial College London
- Enrollment
- 99,999
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Patients diagnosed with acute stroke diagnosed on clinical and neuroimaging grounds who can enter the trial within the 1st week of stroke onset, and who have new motor dysfunction of an upper limb. Motor impairment should be moderate - severe (<50/66 in UE-FM score).
- •2. Age: above 18 years old.
- •3. Patients able and willing to partake in motor tests, and to return for follow-up visit at 12 weeks.
- •4. Able to understand English.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
- •1. Contraindications for donepezil: pregnancy (Female patients of child-bearing potential will be asked if there is any possibility that they might be pregnant. If there is any uncertainty, or a likelihood that they are pregnant, this will qualify as an exclusion criterion); moderate – severe asthma (i.e. regular treatment prescribed for this); bradycardia, syncope, 2nd or 3rd degree heart block, acute or decompensated heart failure; peptic ulcer diagnosed endoscopically and on treatment for this; epilepsy; Parkinson’s disease; end-stage renal failure or creatinine > 300 mcmol/l; genito-urinary tract or gastrointestinal tract obstruction; gastrointestinal tract hemorrhage; myasthenia gravis; on anti-cholinergic therapy for bowel or bladder overactivity
- •2. Other: functionally-significant cognitive impairment (i.e. dementia); significant receptive aphasia (i.e. such that cannot understand purpose or details of trial, and will be unable to cooperate with task instructions); significant physical infirmity as judged by treating physician (e.g. severe organ failure; terminal cancer).
- •3. Contraindications for MRI (this only pertains for the subset of patients entering the MRI substudy, or subjects without prior MRI, but is not a contra-indication to the main study providing a diagnosis of stroke is clear from CT): claustrophobia, metal implants including pacemaker.
Investigators
Similar Trials
Completed
Not Applicable
A randomized study comparing effects of donepezil and galantamine in Alzheimer disease :attentional function of clinical trialAlzhimer diseaseJPRN-UMIN000012544Department of Neuropsychiatry, Keio University School of Medicine,26
Completed
Not Applicable
A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia.s diseaseParkinson's diseaseJPRN-UMIN000010752Kansai Medical University50
Active, not recruiting
Phase 1
Evaluation of the efficacy of donepezil in the treatment of oxaliplatin-induced peripheral neuropathyEUCTR2021-005326-23-FRCHU de Clermont-Ferrand80
Completed
Not Applicable
The efficacy and response of donepezil in severe Alzheimer disease: multi-modal neuroimaging analysis (structural and functional neuroimaging) of open-label, clinical trialAlzheimer diseaseJPRN-UMIN000009473Department of Neuropsychiatry, Keio University School of Medicine48
Completed
Phase 3
Efficacy of Donepezil in the treatment of Major Depressive DisorderMajor Depressive Disorder.Sever Depressive Episode Without Psychotic SymptomsIRCT2013031011885N2Vice chancellor for research, Mazandaran University of Medical Sciences40
