Foslevodopa/Foscarbidopa for Advanced Parkinson's Disease
Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 67
Sex
Any
Study type
Observational
Participants needed
125 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for adults with early advanced Parkinson's disease to see how effective foscarbidopa/foslevodopa is in real-life conditions. Participants will receive the treatment through a method prescribed by their doctor and will be followed for up to 12 months.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease
I am eligible for foscarbidopa/foslevodopa therapy
I am between 18 and 64 years old
I have had motor fluctuations for 3 years or less
My Hoehn and Yahr stage is less than 3 while on medication
My doctor decided I need this treatment before I was asked to join the study
You may not be able to join if
I have previously used any device-aided therapy
I have a condition listed in the contraindications of the therapy
I have a Mini Mental State Examination score below 24
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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
* The Hoehn and Yahr (H\&Y) stage \<= 3
* Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study
Exclusion Criteria:
* 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
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