A prospective, multicenter, single-arm follow-up study to systematically record motor symptoms and associated quality of life in idiopathic Parkinson's patients

A prospective, multicenter, single-arm follow-up study to systematically record motor symptoms and associated quality of life in idiopathic Parkinson's patients - SymptoEase

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032799

Enrollment

100

Registered

2023-10-05

Start date

2023-11-23

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

G20

Interventions

Group 1: Patients with idiopathic Parkinson's disease in a moderate to severe phase with motor symptoms, whereby the individual quality of life is assessed every six months using a validated questionn

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Idiopathic Parkinson's disease - Disease in moderate to severe phase (Hoehn & Yahr scale value: 2.0 to 4.0) - Motor fluctuations (with at least two hours per day in the OFF phase) - Voluntary participation in the study - Signed declaration of consent including data protection declaration - Signed confidentiality agreement - Signed STAT-ON® privacy policy

Exclusion criteria

Exclusion criteria: - Hoehn & Yahr scale value greater than 4.0 - Wheelchair required - Participation in another study - Acute illness affecting the study - Psychiatric or other cognitive impairment that does not allow participation in the study (Mini-Mental Status Test (MMSE) points less than 24)

Design outcomes

Primary

Measure	Time frame
Change in quality of life, determined by mathematical subtraction of the PDQ-8 sum score (PDSI), after survey at six-month intervals	—

Secondary

Measure	Time frame
1. Number of “FoG” episodes in the recording period, 2. Average number of “FoG” episodes per day, 3. Average number of minutes per day that the patient walked, 4. Average number of steps taken per day, 5. Absolute value in hours of diagnosis-free time over the recording period, 6. Absolute value in hours in “OFF” status over the recording period, 7. Absolute value in hours in “INT” status over the recording period, 8. Absolute value in hours in “ON” status over the recording period, 9. Absolute value in hours with dyskinesia over the recording period, 10. Frequency Triggering Event Button STAT ON – Recording when the patient feels the feeling of freezing.	—

Measure

Time frame

1. Number of “FoG” episodes in the recording period, 2. Average number of “FoG” episodes per day, 3. Average number of minutes per day that the patient walked, 4. Average number of steps taken per day, 5. Absolute value in hours of diagnosis-free time over the recording period, 6. Absolute value in hours in “OFF” status over the recording period, 7. Absolute value in hours in “INT” status over the recording period, 8. Absolute value in hours in “ON” status over the recording period, 9. Absolute value in hours with dyskinesia over the recording period, 10. Frequency Triggering Event Button STAT ON – Recording when the patient feels the feeling of freezing.

—

Countries

Germany

Contacts

Public ContactThomas Müller

Alexianer St. Joseph-Krankenhaus Berlin-Weißensee

symptoease.degr@everpharma.com+49 30 2647 98 26

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026