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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Pasquale Fonzetti, MD, PhD, Burke Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01896128
First received: July 2, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Stroke
Cerebrovascular Accident
Hemiparesis
Drug: Armodafinil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Burke Rehabilitation Hospital:

Primary Outcome Measures:
  • Change in Fugl-Meyer Assessment of Sensorimotor Function from Baseline to Discharge [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Change in Functional Independence Measure (FIM) from Baseline to Discharge [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Change in Fugl-Meyer Assessment of Sensorimotor Function from Baseline to Day 100 [ Time Frame: Day 100 ] [ Designated as safety issue: No ]
  • Change in Functional Independence Measure (FIM) from Baseline to Day 100 [ Time Frame: Day 100 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timed 3-Minute Walk Test [ Time Frame: Day 1, Day 12, Day 50, Day 100 ] [ Designated as safety issue: No ]
  • NIH Stroke Scale (NIHSS) [ Time Frame: Day 1, Day 12, Day 100 ] [ Designated as safety issue: No ]
  • 9-Hole Peg Test [ Time Frame: Day 1, Day 12, Day 50, Day 100 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 2, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Burke Rehabilitation Hospital:
stroke
CVA
cerebrovascular accident
hemiparesis
impairment
motor recovery
neuroplasticity
nuvigil
armodafinil

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014