NCT07505394Toboroz
Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 16.
Rövid összefoglaló (regiszter, angolul)
Impulse control disorders and related behaviors (ICDRBs) are characterized by pathological gambling, compulsive shopping or eating, and hypersexuality, but other related behaviors have been described, e.g. hobbyism, and punding. ICDRBs are frequent in Parkinson's Disease (PD), affecting up to 50% of the patients after 5 years with major medical, social, and legal impact, with life changing consequences for patients and caregivers. The main risk factor is dopaminergic therapy, particularly the cumulative dose of dopamine agonists (DA). On the other hand, the dopaminergic therapy is necessary to control motor symptoms, and DA have demonstrated efficacy in delaying motor complications occurring in PD. Ideally, dopaminergic therapy would have to be adjusted to the individual risk of developing ICRDBs to maximize the benefit/risk ratio of each drug. However, despite several clinical risk factors associated with the risk of ICDRBs (in addition to the dopaminergic therapy), it is still not possible to predict their risk at the individual level, and not every patient treated with dopaminergic medications will develop ICDRBs. A machine learning algorithm to predict ICDRBs, based on clinical data, validated by cross-validation on independent replication cohorts has been developed. The PREVENT-ICD study proposes to test the efficacy of a new application, ICD-Shield, based on an algorithm to predict and prevent ICDs,in a multicenter randomized controlled trial to prevent ICDRBs in PD patients by proposing to the clinician treatment adjustment according to the risk predicted by the algorithm, as compared to the standard of care (SoC)
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 528 (tervezett)
- Első benyújtás
- 2026. márc. 26.
- Kezdés
- 2026. okt. 13.
- Elsődleges befejezés
- 2031. okt. 15.
- Fő szponzor
- Assistance Publique - Hôpitaux de Paris
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07505394
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 528
- 2026. okt. 13. és az elsődleges befejezés (2031. okt. 15.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Laborértékek
- Atypical or secondary parkinsonism such as supranuclear palsy, multisystem atrophy or drug-induced parkinsonism, etc...
- Patients with a cognitive or psychiatric disorder preventing patient's participation as per investigator's judgement
- Not willing to participate to the Clinical Investigation or to sign the consent
- Pregnant or lactating woman, or WOCBP tested positive in <serum or urine> pregnancy test
- Participation in investigational drug trials within 30 days prior to screening or within 5 half-life of investigational product whatever the longest
- Participant not affiliated or beneficiary of a French social security system
Kiket keres a vizsgálat
- Male and female ≥ 18 years old
- Diagnosis of PD according to the 2015 Movement Disorders Society criteria (Postuma et al., Mov Disord. 2015), with bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor; with no other suspected cause of parkinsonism
- Disease duration below 6 years included
- No ongoing clinically significant (Mild or above) ICDRBs (any ASBPD part IV subscores in any of the items 3 to 5 and 7 to 10 each <2)
- Patients currently treated with DA for at least 2 months and without current planned or known reason for stopping DA over the next 3 years
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHU Pitié Salpêtrière, APHP service de neurologie | Paris | Franciaország | Toboroz |
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