Atomoxetine HydrochloridePhase 2NCT02788357
Post-stroke Neural Plasticity With Atomoxetine
A Phase 2 study testing Atomoxetine in people with Atomoxetine Hydrochloride and Placebos, run by Lumy Sawaki.
Trial summary
This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Atomoxetine Hydrochloride, Placebos
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Dec 2014
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke patients
- Single stroke
- Chronic (more than 6 months after from stroke)
- At least 21 years old, but there is no upper age range for this project.
- Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Who cannot join
- History of head injury with loss of consciousness
- History of severe alcohol or drug abuse
- History of psychiatric illness
- Unstable cardiac dysrhythmia
- High blood pressure (systolic pressure >160 mm Hg and/or diastolic pressure >100 mm Hg)
- History of myocardial infarction or unstable angina
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- Pregnancy
- Glaucoma, history of hypersensitivity or idiosyncrasy to sympathomimetic drugs.
- Subjects using drugs suspected of interfering with plasticity, such as MAOI, alpha-adrenergic antagonists, benzodiazepines, muscarinic receptor antagonists, dopaminergic antagonists, or other neuroleptics within 3 months of recruitment.
About this study
Official title: Enhancement of Post-stroke Neural Plasticity With Atomoxetine: a Pilot Study
This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.
Read the detailed description
Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.
- Conditions
- Atomoxetine Hydrochloride, Placebos
- Being tested
- Atomoxetine, Placebo
- Keywords
- motor training, motor recovery, human, neuroplasticity, transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Also called Strattera
Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
PlaceboDrug
Also called Sham
Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine with motor training | Experimental | 40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays Receives: Drug: Atomoxetine |
| Placebo with motor training | Placebo comparator | Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays 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
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
Measured: baseline, post-intervention, 1-month follow-up
Secondary outcomes (3)
Change in Action Arm Research Test (ARAT)
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.
Measured: baseline, post-intervention, 1-month follow-up
Change in Wolf Motor Function Test (WMFT)
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.
Measured: baseline, post-intervention, 1-month follow-up
Transcranial Magnetic Stimulation
Measured: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startNov 2006
- Primary completionDec 2012
- Study completionDec 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atomoxetine HydrochlorideStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumy Sawaki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lumy Sawaki, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788357
- Sponsor's protocol ID
- No ID
- Status last verified
- Jul 2017
- First submitted
- 27 May 2016
- Last updated
- 14 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ward A, Carrico C, Powell E, Westgate PM, Nichols L, Fleischer A, Sawaki L. Safety and improvement of movement function after stroke with atomoxetine: A pilot randomized trial. Restor Neurol Neurosci. 2017;35(1):1-10. doi: 10.3233/RNN-160673.
PubMed 27858723
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Post-stroke Neural Plasticity With Atomoxetine: a Pilot Study
- ClinicalTrials.gov ID
- NCT02788357
- Acronym / sponsor ID
- No ID
- Conditions
- Atomoxetine Hydrochloride, Placebos
- Keywords
- motor training, motor recovery, human, neuroplasticity, transcranial magnetic stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lumy SawakiUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Posted 14 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.
Detailed description
Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.
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 |
|---|---|---|
| Atomoxetine with motor training | Experimental | Drug: Atomoxetine40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays |
| Placebo with motor training | Placebo comparator | Drug: PlaceboPlacebo capsules paired with task-oriented therapy for 10 consecutive weekdays |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic stroke patients
- Single stroke
- Chronic (more than 6 months after from stroke)
- At least 21 years old, but there is no upper age range for this project.
- Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Key exclusion criteria (9 listed)
- History of head injury with loss of consciousness
- History of severe alcohol or drug abuse
- History of psychiatric illness
- Unstable cardiac dysrhythmia
- High blood pressure (systolic pressure >160 mm Hg and/or diastolic pressure >100 mm Hg)
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 |
|---|---|---|
| AtomoxetineAlso: StratteraSubjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake. | Drug | Atomoxetine with motor training |
| PlaceboAlso: ShamSubjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake. | Drug | Placebo with motor training |
Primary outcome
Change in Fugl Meyer Assessment
Time frame: baseline, post-intervention, 1-month follow-up
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
3 secondary outcomes
Change in Action Arm Research Test (ARAT)
Time frame: baseline, post-intervention, 1-month follow-up
Change in Wolf Motor Function Test (WMFT)
Time frame: baseline, post-intervention, 1-month follow-up
Transcranial Magnetic Stimulation
Time frame: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27858723Ward A, Carrico C, Powell E, Westgate PM, Nichols L, Fleischer A, Sawaki L. Safety and improvement of movement function after stroke with atomoxetine: A pilot randomized trial. Restor Neurol Neurosci. 2017;35(1):1-10. doi: 10.3233/RNN-160673.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atomoxetine in people with Atomoxetine Hydrochloride and Placebos, run by Lumy Sawaki.
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 5 inclusion and 9 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 14 Aug 2017). 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 (time frame: baseline, post-intervention, 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788357, which also lists 1 linked publication.
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 14 Aug 2017.