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

NCT01896128 | Completed Phase 2 Results

• 1 other identifier: BRC-394
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; CVA; cerebrovascular accident; hemiparesis; impairment; motor recovery; neuroplasticity; nuvigil; armodafinil

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100

  Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. The five domains assessed by Fugl-Meyer scale are: * Motor function (Maximum score in upper limb = 66;Maximum score in lower limb = 34) * Sensory function (Maximum score = 24) * Balance (Maximum score = 14) * Range of motion of joints (Maximum score = 44) * Joint pain (Maximum score = 44)

  Baseline to Day 100

Secondary Outcomes (4)

• Change in Functional Independence Measure (FIM) From Baseline to Day 100

  Day 100

• Timed 3-Minute Walk Test From Baseline to Day 100

  Day 1, Day 100

• NIH Stroke Scale (NIHSS)

  Baseline Day 100

• 9-Hole Peg Test

  Baseline & Day 100

Study Arms (2)

Armodafinil

EXPERIMENTAL

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

Drug: Armodafinil

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Armodafinil DRUG

Also known as: Nuvigil

Armodafinil

Placebo DRUG

inactive pill manufactured to mimic Armodafinil 150 mg tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burke Rehabilitation Hospital: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

The Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Pasquale Fonzetti MD
• Organization: Burke Rehabilitation Hospital

pfonzett@burke.org

(914) 597-2502

Study Officials

• Pasquale Fonzetti, MD, PhD

  The Burke Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Memory Evaluation and Treatment Service

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 11, 2013
• Study Start: January 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 4, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-10

Locations

US (1)