Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease

Study acronym: PREVENT-ICD
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 1, 2031 → Oct 15, 2031
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Record History

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  1. Notable Recruitment opened Show 6 more changesShow less
    • Start date changed from estimate of Jul 1, 2026 to Oct 13, 2026
    • Primary and study completion pushed from Jun 1, 2031 to Oct 15, 2031
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 11 of 23 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Notable Primary and study completion pushed from Jun 1, 2030 to Jun 1, 2031v2 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Jun 1, 2026 to Jul 1, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 23 of 23 entries
    • Study description revised
  3. Minor 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.
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)
Trial Details
NCT Number NCT07505394
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: NS-PARK Network
Conditions
(from sponsor)
Parkinson Disease, Impulse Control Disorder
Related terms Disruptive, Impulse Control, and Conduct Disorders, Parkinson Disease
Enrollment 528 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov