Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-67
SponsorAbbVie

About this trial

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice.

Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany.

Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease

Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label

Participant must be an adult male or female, 18-67 years of age

Time since beginning of motor fluctuations <= 5 years

Disqualifiers

Previous Exposure to any device-aided therapy (DAT).

Any condition included in the contraindications section of the approved local LDp/CDp label.

Participants with Mini mental state examination (MMSE) score < 24

Trial population

Participants with advanced Parkinson's disease with time since the beginning of motor fluctuations \<= 5 years and the Hoehn and Yahr (H\&Y) stage \<= 3 in the on-medication condition treated with foslevodopa/foscarbidopa according to label in Germany

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

125 Participants
are grouped into 1 trial group
Group A: Foslevodopa/Foscarbidopa

Trial outcomes

Primary outcomes

1

Change From Baseline in OFF Time (hours)

The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).

Time frame
Up to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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