StrokePhase 2NCT01896128
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
A Phase 2 study testing Armodafinil in people with Stroke and Cerebrovascular Accident, run by Burke Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Hemiparesis
- What is being tested?
- Armodafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Burke Rehabilitation Hospital
White Plains, New York, 10605
About this study
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
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
- Being tested
- Armodafinil, Placebo
- Keywords
- stroke, CVA, cerebrovascular accident, hemiparesis, impairment, motor recovery, neuroplasticity, nuvigil, armodafinil
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
Also called Nuvigil
PlaceboDrug
inactive pill manufactured to mimic Armodafinil 150 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Armodafinil | Experimental | 150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days Receives: Drug: Armodafinil |
| Placebo | Placebo comparator | inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Day 100
Secondary outcomes (4)
Change in Functional Independence Measure (FIM) From Baseline to Day 100
The FIM is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires.
The motor subscale includes:Eating,Grooming,BathingDressing, upper body,Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchairTransfers - toiletTransfers - bath/showerWalk/wheelchairStairs The cognition subscale includes:Comprehension ExpressionSocial interaction Problem solvingMemory Each item is scored on a 7 point ordinal scale, ranging from a score of 1(worse) to a score of 7(better). The total score for the FIM motor subscale (the sum of motor subscale ) will be a value between 13 and 91.The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5(worse outcome) \& 35(best outcome).The total score for the FIM instrument (the sum of subscale scores) will be a value between 18(worse outcome) \& 126 (best outcome)
Measured: Day 100
Timed 3-Minute Walk Test From Baseline to Day 100
The 3MWT is a simple measure of the distance a person can walk in three minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used.A clear course such as a hallway with cones or similar to mark an approximately 15m "out and back" course[8], stopwatch, pen and paper or a device to record distance walked.
Measured: Day 1, Day 100
NIH Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 Score.
Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Measured: Baseline Day 100
9-Hole Peg Test
9 HOLE PEG TEST
- Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible
- Participants must then remove the pegs from the holes, one by one, and replace them back into the container
- The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested
- Only the hand being evaluated should perform the test
- Hand not being evaluated is permitted to hold the edge of the board in order to provide stability
- Scores are based on the time taken to complete the test activity, recorded in seconds
- Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second
- Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container
Measured: Baseline & Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJan 2008
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burke Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Principal investigator, Pasquale Fonzetti, MD, PhD, Burke Rehabilitation Hospital
- Investigators
- Pasquale Fonzetti, MD, PhD, Principal investigator, The Burke Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896128
- Sponsor's protocol ID
- BRC-394
- Status last verified
- Oct 2019
- First submitted
- 2 Jul 2013
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01896128
- Acronym / sponsor ID
- BRC-394
- Conditions
- Stroke, Cerebrovascular Accident, Hemiparesis
- Keywords
- stroke, CVA, cerebrovascular accident, hemiparesis, impairment, motor recovery, neuroplasticity, nuvigil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Burke Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Jan 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armodafinil | Experimental | Drug: Armodafinil150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days |
| Placebo | Placebo comparator | Drug: Placeboinactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Age less than 18
- Previous clinical stroke
- Pregnant and/or nursing patients
- Major psychiatric history, including psychosis and history of substance abuse
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmodafinilAlso: Nuvigil | Drug | Armodafinil |
| Placeboinactive pill manufactured to mimic Armodafinil 150 mg tablet | Drug | Placebo |
Primary outcome
Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
Time frame: 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)
4 secondary outcomes
Change in Functional Independence Measure (FIM) From Baseline to Day 100
Time frame: Day 100
Timed 3-Minute Walk Test From Baseline to Day 100
Time frame: Day 1, Day 100
NIH Stroke Scale (NIHSS)
Time frame: Baseline Day 100
9-Hole Peg Test
Time frame: Baseline & Day 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale Fonzetti, MD, PhD principal investigator
The Burke Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Armodafinil in people with Stroke and Cerebrovascular Accident, run by Burke Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100 (time frame: Baseline to Day 100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.