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

Recruiting

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00032799
• Lead Sponsor: EVER Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

- 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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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