Drug Induced Dyskinesia Clinical Trials

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A Global Real-World Evidence Study on the Effectiveness and Safety/Tolerability of Foslevodopa/Foscarbidopa in Patients Earlier Within Advanced Parkinson's Disease

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
SUMMARY

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 Foslevodopa/Foscarbidopa is in treating adult participants earlier within advanced Parkinson disease under routine clinical practice. Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 100 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 40 sites across the world. Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 6 months. There are no additional examinations due to the study but the participants and caregivers will need to fill several questionnaires to generate data on their motor function and well-being

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Eligibility for Foslevodopa/Foscarbidopa (LDp/CDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable

• A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD)

• Adult male or female between 18 and 80 years of age

• Disease duration (time since diagnosis) \<10 years

• Time since motor fluctuations ≤3 years

• H\&Y Stage \<3 in best on

• off time of 2.5-6 hours per day

• Naïve to LDp/CDp

• Treatment has been optimized with oral/transdermal PD medication in the opinion of the Investigator

• Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in the study

• Willing and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (tablet).

• Prior to any study-related procedures being performed, the participant or Legal Authorized Representative (LAR) must voluntarily sign an Authorization for Use/Disclosure of Data (AUDD)/Informed Consent Form (ICF) according to national regulations once the study has been explained and the participant has the opportunity to have any questions answered

Locations
United States
Texas
Texas Movement Disorder Specialists /ID# 278565
RECRUITING
Georgetown
Other Locations
Israel
Hadassah Medical Center-Hebrew University /ID# 276211
RECRUITING
Jerusalem
Shaare Zedek Medical Center /ID# 276209
RECRUITING
Jerusalem
The Chaim Sheba Medical Center /ID# 276210
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 276212
RECRUITING
Tel Aviv
Romania
Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499
NOT_YET_RECRUITING
Brasov
Fundeni Clinical Institute /ID# 277490
RECRUITING
Bucharest
Arcadia Spitale Si Centre Medicale /Id# 277525
RECRUITING
Iași
Neurotim Med /ID# 277500
RECRUITING
Timișoara
United Kingdom
University Hospitals Plymouth NHS Trust /ID# 284977
RECRUITING
Plymouth
Contact Information
Primary
Lars Bergmann
lars.bergmann@abbvie.com
+49(0)170 4538568
Time Frame
Start Date: 2026-08-03
Estimated Completion Date: 2027-10
Participants
Target number of participants: 100
Treatments
Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov