Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

NCT ID: NCT01896128

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-07-31

Brief Summary

Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients.

The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.

Conditions

Stroke; Cerebrovascular Accident; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

inactive pill manufactured to mimic Armodafinil 150 mg tablet

Armodafinil

150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Interventions

Armodafinil

Intervention Type: DRUG

Placebo

inactive pill manufactured to mimic Armodafinil 150 mg tablet

Intervention Type: DRUG

Other Intervention Names

Nuvigil

Eligibility Criteria

Inclusion Criteria

• First clinical stroke, either cerebral infarction or intracerebral hemorrhage
• Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25
• Screening Motricity Index score of 0-83
• Date of stroke onset between 7 to 21 days prior to study inclusion

Exclusion Criteria

• Age less than 18
• Previous clinical stroke
• Pregnant and/or nursing patients
• Major psychiatric history, including psychosis and history of substance abuse
• Dementia
• Known CNS pathology such as brain tumor
• Significant language dysfunction or severe neglect that hinders comprehension, participation, and barrier to testing
• Seizures
• Left ventricular hypertrophy (LVH)
• Mitral valve prolapse (MVP)
• Severe chronic renal failure or severe hepatic failure
• History or current use of anti-epileptic medications, psychostimulants, or neuroleptics
• Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal contraceptives, cyclosporine, or theophylline

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: collaborator

Burke Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pasquale Fonzetti, MD, PhD

Associate Director, Memory Evaluation and Treatment Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pasquale Fonzetti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Burke Rehabilitation Hospital

Locations

The Burke Rehabilitation Hospital

White Plains, New York, United States

Countries

United States

Other Identifiers

BRC-394

Identifier Type: -

Identifier Source: org_study_id