Phase 2 Completed N=12 Randomized Quadruple-blind Treatment

Post-stroke Neural Plasticity With Atomoxetine

Atomoxetine Hydrochloride · Placebos

Source: ClinicalTrials.gov NCT02788357 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcomePrimary: Change in Fugl Meyer Assessment — 9.3; 2.2; 11.9; 5.8 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Fugl Meyer Assessment	9.3; 2.2; 11.9; 5.8	—
SECONDARY Change in Action Arm Research Test (ARAT)	7.7; 5.3; 10.1; 6.5	—
SECONDARY Change in Wolf Motor Function Test (WMFT)	-0.1; -0.19; -0.11; -0.2	—
SECONDARY Transcranial Magnetic Stimulation	—	—

Eligibility Criteria

Inclusion Criteria

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°.

Exclusion Criteria

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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02788357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.