Does the drug Pramipexole improve the verbal communication ability of stroke patients with impaired language function?
- Conditions
- Post-stroke aphasiaTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002396-17-GB
- Lead Sponsor
- Birmingham Community Healthcare NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
First-ever stroke at least 6 months prior to the start of the study and resulting in severe or moderately severe predominantly expressive aphasia.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Parkinson’s disease
Major depressive illness
Significant cognitive impairment
Severe renal impairment
Known hypersensitivity to dopamine agonists, pregnancy, breast feeding or psychosis Patients for whom English is not the first language will also be excluded because of concerns about the validity and reliability of the translated versions of the Western Aphasia Battery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does Pramipexole when combined with standard speech and language therapy improve the clinical outcomes better than standard speech and language therapy alone in chronic post-stroke aphasia?;Secondary Objective: NA;Primary end point(s): Change in language function as measured with the Western Aphasia Battery;Timepoint(s) of evaluation of this end point: Completition of treatment and follow up - end of week 8 of study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA