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

In post stroke patients, treatment with nefiracetam decreases the severity of apathy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000975291

Enrollment

Registered

2009-11-11

Start date

2010-07-27

Completion date

2013-03-22

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The successful psycho-physical rehabilitation of stroke victims remains challenging. Recent advances have resulted in progress in acute treatment of stroke, however post-acute rehabilitation remains basically unchanged. One reason for this is the high frequency of emotional and behavioural disorders post-stroke, such as apathy. Apathy is associated with greater deficits in activities of daily living, more severe cognitive deficits, longer hospital stay, and worse rehabilitation and functional outcomes. There are no known effective pharmacological or psychological treatments for apathy after stroke. We aim to determine if treatment with nefiracetam decreases the severity of post-stroke apathy. We will also test whether nefiracetam results in greater improvement on functional and social impairments, quality of life and cognition as compared to placebo.

Interventions

450mg Nefiracetam (one capsule orally) twice daily for 12 weeks

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to 90 Years

Healthy volunteers

Yes

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

Outcome results