NCT07227896Toboroz
Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease
A Global Real-World Evidence Study on the Effectiveness and Safety/Tolerability of Foslevodopa/Foscarbidopa in Patients Earlier Within Advanced Parkinson's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 1.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2025. nov. 10.
- Kezdés
- 2026. aug. 3.
- Elsődleges befejezés
- 2027. okt.
- Fő szponzor
- AbbVie
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07227896
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 100
- 2026. aug. 3. és az elsődleges befejezés (2027. okt.) között
- 10 helyszín, 4 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- History of treatment with any Device-Aided Therapy (DAT), such as Deep Brain Stimulation (DBS), Continuous Subcutaneous Apomorphine Infusion (CSAI), Levodopa/Carbidopa Intestinal Gel (LCIG)/ Carbidopa/Levodopa Enteral Suspension (CLES), Levodopa/Entacapone/Carbidopa Intestinal Gel (LECIG)
- Participation in a concurrent investigational or observational clinical trial
Más betegség
- History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country
- History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis). In case of temporary affections like recent sunburn or open wounds, or in case of permanent affections like acne, scar tissue, tattoo, branding, or colorations, the participant should not be included if the Investigator considers these as interfering with infusion of study drug or study assessments.
Egyéb
- Mini-Mental State Examination (MMSE) score <24
- Lack of motivation/insufficient language skills to complete the study questionnaires
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (10)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospitals Plymouth NHS Trust /ID# 284977 | Plymouth | Egyesült Királyság | Toboroz |
| Shaare Zedek Medical Center /ID# 276209 | Jerusalem | Izrael | Toboroz |
| Hadassah Medical Center-Hebrew University /ID# 276211 | Jerusalem | Izrael | Toboroz |
| The Chaim Sheba Medical Center /ID# 276210 | Ramat Gan | Izrael | Toboroz |
| Tel Aviv Sourasky Medical Center /ID# 276212 | Tel Aviv | Izrael | Toboroz |
| Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499 | Brasov | Románia | Toborzás még nem indult |
| Fundeni Clinical Institute /ID# 277490 | Bucharest | Románia | Toboroz |
| Arcadia Spitale Si Centre Medicale /Id# 277525 | Iași | Románia | Toboroz |
| Neurotim Med /ID# 277500 | Timișoara | Románia | Toboroz |
| Texas Movement Disorder Specialists /ID# 278565 | Georgetown | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.