Efficacy of amantadine in acquired brain injury.
- Conditions
- behavioural and emotional problems and impairment of executive functioning due to acquired brain injury to the frontal lobesTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-005723-33-NL
- Lead Sponsor
- GGZ Oost Brabant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
• Subjects have suffered acquired brain damage due to various aetiologies as verified by CT or MRI • Subjects suffer from emotional lability/irritability, aggressiveness, apathy as established through clinical observation and/or impairment of executive functioning as established by clinical judgement or on the basis of neuropsychological assesment. • Subjects are >3 months post injury • Subjects are 18 years or older • Written informed consent is given
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Current drug addiction
• Current psychoses • The current use of incompatible medications: methylphenidate, typical or atypical antipsychotics, combination diuretics (hydrochlorthiazide + potassium sparing diuretics) or Levodopa. • Pregnancy and lactation • Cardiac disease. Inclusion only after the consulting cardiologists consent • Refractory epilepsy • Kidney failure (eGFR<10 ml/min) • A history of gastric ulceration • Current glaucoma • Hypersensitivity to amantadine or any of the excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method