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

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ClinicalTrials.gov Identifier: NCT01896128
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Pasquale Fonzetti, MD, PhD, Burke Rehabilitation Hospital

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.


Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Accident Hemiparesis Drug: Armodafinil Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of a Wakefulness-Promoting Agent (Armodafinil) Combined With Neuro-rehabilitation to Improve Neurological Recovery and to Reduce the Incidence of Disability in Patients Who Suffered a Stroke
Study Start Date : January 2008
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Armodafinil
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Drug: Armodafinil
Other Name: Nuvigil
Placebo Comparator: Placebo
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Drug: Placebo
inactive pill manufactured to mimic Armodafinil 150 mg tablet



Primary Outcome Measures :
  1. Change in Fugl-Meyer Assessment of Sensorimotor Function from Baseline to Discharge [ Time Frame: Day 12 ]
  2. Change in Functional Independence Measure (FIM) from Baseline to Discharge [ Time Frame: Day 12 ]
  3. Change in Fugl-Meyer Assessment of Sensorimotor Function from Baseline to Day 100 [ Time Frame: Day 100 ]
  4. Change in Functional Independence Measure (FIM) from Baseline to Day 100 [ Time Frame: Day 100 ]

Secondary Outcome Measures :
  1. Timed 3-Minute Walk Test [ Time Frame: Day 1, Day 12, Day 50, Day 100 ]
  2. NIH Stroke Scale (NIHSS) [ Time Frame: Day 1, Day 12, Day 100 ]
  3. 9-Hole Peg Test [ Time Frame: Day 1, Day 12, Day 50, Day 100 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896128


Locations
United States, New York
The Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Sponsors and Collaborators
Burke Rehabilitation Hospital
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Pasquale Fonzetti, MD, PhD The Burke Rehabilitation Hospital

Responsible Party: Pasquale Fonzetti, MD, PhD, Associate Director, Memory Evaluation and Treatment Service, Burke Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01896128     History of Changes
Other Study ID Numbers: BRC-394
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Pasquale Fonzetti, MD, PhD, Burke Rehabilitation Hospital:
stroke
CVA
cerebrovascular accident
hemiparesis
impairment
motor recovery
neuroplasticity
nuvigil
armodafinil

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action