Levodopa in early Parkinson*s disease;LEAP-5Y-study: Follow-up of the Levodopa in early Parkinson's disease study

Levodopa in early Parkinson*s disease;LEAP-5Y-study: Follow-up of the Levodopa in early Parkinson's disease study - LEAP-study;LEAP-5Y-study: Acroniem follow-up trial: LEAP-5Y-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55477

Enrollment

446

Registered

2011-02-25

Start date

2011-08-19

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Parkinson's disease

Interventions

40 weeks treatment with levodopa/carbidopa 100/25 mg TID (including 2 weeks of dose escalation) or 40 weeks placebo TID (phase 1). Following phase 1, all patients will receive levodopa/carbidopa 100

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are: * idiopathic PD (13) with bradykinesia and at least two of the following signs: * resting tremor; * rigidity; * asymmetry. * newly diagnosed PD within the past two years; * age 30 years and over; * a life expectancy of more than two years; * no limitations in functional health for which the patient needs PD-medication., LEAP-5Y-study: * Participation in the LEAP-study * Patients that gave permission to be contacted about a follow-up study

Exclusion criteria

Exclusion criteria: The exclusion criteria are: * tremor as most prominent symptom, such as (13): * a severe resting tremor that is present (almost) continuously; * tremor of medium to large amplitude which results in functional disability (such as interfering with feeding) * previous treatment with PD-medication, e.g., levodopa, DA, MAO-B-inhibitor, catechol-O-methyl transferase-inhibitor (COMT-inhibitor), or amantadine; * cognitive impairments, i.e., Mini Mental State Examination (MMSE) of 23 points or lower (14); * more than 28 points on the Beck Depression Scale II (BDI-II) (15); * diagnosis of depression by a psychiatrist in the last year; * history of psychosis; * the presence of signs indicating atypical or secondary parkinsonism such as: * the use of drugs that may cause parkinsonism (e.g., metoclopramide, cinarizine, anti-psychotics, natrium-valproate, lithium, amiodarone); * metabolic disorders (e.g., Wilson*s disease); * encephalitis; * vascular parkinsonism; * repeated head-trauma., * untreated closed-angle glaucoma; * alcohol abuse; * pregnancy * legally incompetent adults; * inability to provide written informed consent., LEAP-5Y-study: * Inability to provide written informed consent * Legally incompetent adult

Design outcomes

Primary

Measure	Time frame
The primary clinical outcome measure is the difference in the mean total UPDRS scores between the early and delayed groups at 80 weeks. Ancillary diagnostic accuracy study: The primary outcome measure is the diagnostic accuracy of the different parameters of neurological examination, which will be expressed in terms of sensitivity, specificity and predictive values. LEAP-5Y-study: The difference between the mean total UPDRS score of the early- and delayed start group of the LEAP-study, measured 5 years after baseline of the LEAP-study.	—

Measure

Time frame

The primary clinical outcome measure is the difference in the mean total UPDRS scores between the early and delayed groups at 80 weeks. Ancillary diagnostic accuracy study: The primary outcome measure is the diagnostic accuracy of the different parameters of neurological examination, which will be expressed in terms of sensitivity, specificity and predictive values. LEAP-5Y-study: The difference between the mean total UPDRS score of the early- and delayed start group of the LEAP-study, measured 5 years after baseline of the LEAP-study.

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Secondary

Measure	Time frame
Secondary outcomes are the progression of symptoms in phase 1 and phase 2 measured with the UPDRS; ALDS; between-group difference in mean total UPDRS scores at 80 weeks and the progression of UPDRS scores during phases 1 and 2 in patients who followed the study per protocol; between-group difference in mean total UPDRS scores at 80 weeks and the progression of UPDRS scores during phases 1 and 2 in patients with UPDRS scores in the highest quartile of scores at baseline who followed the study per protocol; number of patients that need additional medication for PD; cognitive impairment, measured with the MMSE; depression, measured with the BDI-II; perceived quality of life measured with the PDQ-39; ability to (maintain) work, the use of (informal) care; caregiver burden; costs; number of patients withdrawn from the study or lost to follow up; dyskinesias, levodopa-induced motor response fluctuations, and (serious) adverse events. LEAP-5Y-study: - The progression of symptoms between 80 weeks and 5 years after baseline of the LEAP-study measured with the UPDRS of the early start group as compared to the delayed start group - The difference in levodopa induced motor response fluctuations between the early and delayed start group at visit 10; the frequency, severity, nature, and duration of any levodopa induced motor response fluctuation, measured by part IV of the MDS-UPDRS - Use of PD-drugs and corresponding levodopa equivalent dose (LED) at 3 and 5 years after baseline of the LEAP-study - Non-motor symptoms, 5 years after baseline of the LEAP-study (measured by the MDS-UPDRS part I and SCOPA-Aut) - Cognitive impairment, measured with the MoCA - Clinical diagnosis 5 years after baseline of the LEAP-study according to the patient*s own neurologists;	—

Measure

Time frame

Secondary outcomes are the progression of symptoms in phase 1 and phase 2 measured with the UPDRS; ALDS; between-group difference in mean total UPDRS scores at 80 weeks and the progression of UPDRS scores during phases 1 and 2 in patients who followed the study *per protocol*; between-group difference in mean total UPDRS scores at 80 weeks and the progression of UPDRS scores during phases 1 and 2 in patients with UPDRS scores in the highest quartile of scores at baseline who followed the study *per protocol*; number of patients that need additional medication for PD; cognitive impairment, measured with the MMSE; depression, measured with the BDI-II; perceived quality of life measured with the PDQ-39; ability to (maintain) work, the use of (informal) care; caregiver burden; costs; number of patients withdrawn from the study or lost to follow up; dyskinesias, levodopa-induced motor response fluctuations, and (serious) adverse events. LEAP-5Y-study: - The progression of symptoms between 80 weeks and 5 years after baseline of the LEAP-study measured with the UPDRS of the early start group as compared to the delayed start group - The difference in levodopa induced motor response fluctuations between the early and delayed start group at visit 10; the frequency, severity, nature, and duration of any levodopa induced motor response fluctuation, measured by part IV of the MDS-UPDRS - Use of PD-drugs and corresponding levodopa equivalent dose (LED) at 3 and 5 years after baseline of the LEAP-study - Non-motor symptoms, 5 years after baseline of the LEAP-study (measured by the MDS-UPDRS part I and SCOPA-Aut) - Cognitive impairment, measured with the MoCA - Clinical diagnosis 5 years after baseline of the LEAP-study according to the patient*s own neurologists;

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)