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

StatusRecruiting
PhaseNot specified
SponsorAbbVie
Started

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Trial flagged as At Risk
Primary completion moved at least 8 months later Sep 2027 → Jun 2028
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Record History

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  1. Primary and study completion pushed from Sep 2027 to Jun 2028
    • Start date: May 6, 2025 to May 5, 2025
    • Site details revised at 19 of 19 sites
    • Eligibility criteria expanded, about 5 words
  2. Study sites: 17 to 19v7
  3. Study sites revised (17)v6
  4. Study sites: 13 to 17v5
  5. Study sites: 10 to 13v4
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  1. Study sites: 5 to 10v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 5
    • Start date changed from estimate of Apr 30, 2025 to May 6, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Parkinson's Disease
1,462 trials monitored
See 71 trials at risk
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 Details
NCT Number NCT06916507
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Parkinson's Disease
Related terms Parkinson Disease
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov