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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43508
Enrollment
66
Registered
2016-06-09
Start date
2016-08-17
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplantation

Interventions

At baseline, participants will undergo pharmacokinetic testing, a quality of life assessment and a computerized neuropsychological test battery (the Amsterdam Neuropsychological Tasks or ANT battery

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Secondary

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

Primary

MeasureTime frame
The primary outcome is tremor as measured by the ANT Modules Pursuit and Tracking.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)