A randomised double blind, placebo-controlled study of Nefiracetam in patients with post- stroke apathy

Phase 2

Completed

• Conditions: Post stroke apathy; Mental Health - Other mental health disorders

• Registration Number: ACTRN12609000975291
• Lead Sponsor: Fremantle Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Clinical and neurological findings consistent with either hemispheric, brainstem or cerebellar stroke 2. apathy present after stroke 3. able to undergo assessment and take oral medication 4.be cared for by a reliable spouse who can be responsible for administering dose

Exclusion Criteria

1. patients with major depression post stroke 2. stroke resulting from aneurysm, ateriovenous malformation, head injury, intracranial tumour or neoplastic process 3. prestroke dementia 4. severe language comprehension deficits 5. comorbid alcohol or drug abuse 6. severe medical comorbidity 7. current use of neuroleptic or drugs repported to affect apathy 8. apathy resulting from any condition other than stroke 9. Severe renal disease: BUN >=17.85mmol/L; Creatinine >= 176.89 umol/L; proteinuria (dipstick >= +2

Study & Design

• Study Type: Interventional
• Study Design: Not specified