A trial of donepezil for improving recovery after stroke

Phase 1

• Conditions: Acute stroke (ischemic and hemorrhagic strokes, starting within 4 days of onset); MedDRA version: 14.0 Level: LLT Classification code 10048863 Term: Hemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-024048-14-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-26
• Study Completion: 2015-01-01
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 99999

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified