THE TREMOR STUDY: TACROLIMUS EXTENDED RELEASE, MOVEMENT DISORDERS AND OTHER NEUROCOGNITIVE EFFECTS

Phase 4

Completed

• Conditions: kidney transplantation; 10029149

• Registration Number: NL-OMON43508
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

Age between 18-70 years
Recipient of a kidney transplantation more than one year ago
On a triple-low-dose immunosuppressive regimen including tacrolimus
Suffering from a tremor
Stable renal function
Able to give informed consent

Exclusion Criteria

Not being able to understand the instructions for the tests
Chronic diarrhea
Use of protease inhibitors, azoles or sedatives
Thyroid dysfunction
Active psychiatric or neurologic disease
Use of psychotropic drugs, antiepileptics or B2-agonists
Excessive use of caffeine (more than 5 I.E. per day)
Excessive use of alcohol (more than 2 I.E. per day)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is tremor as measured by the ANT Modules Pursuit and<br /><br>Tracking. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include (1) a selection of neuropsychological assessments<br /><br>from the ANT test battery, (2) tremor as measured by TETRAS (TRG Essential<br /><br>Tremor Rating Assessment Scale), (3) a quality of life assessment and (4)<br /><br>patient drug preference at the end of study.</p><br>