Prediction-model guided drug choice to prevent impulse control disorders in Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study is a multicenter randomized, controlled trial comparing an algorithm-guided dopaminergic prescription strategy (using the ICD SHIELD app) against standard care in Parkinson’s patients at risk for impulse control disorders. Participants are adults with Parkinson’s treated with dopamine agonists who do not currently have clinically significant ICDs. The primary endpoint assesses the impact of the algorithm-guided approach on impulse control outcomes over 36 months, with multiple clinical, cognitive, and patient-reported assessments collected at baseline and during follow-up visits. The trial uses masked evaluation and follows patients in specialist centers within the NSPARK/FRIN network to determine if personalized, algorithm-assisted prescribing can improve safety without compromising motor control. Outcomes include motor scales, quality of life, and neuropsychological measures, analyzed to determine superiority of the algorithm-guided strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• CHU Pitié Salpêtrière, APHP service de neurologie
  Paris, France Recruiting

Study contacts

• Study coordinator: Louise-Laure Mariani, Doctor
• Email: louise-laure.mariani@aphp.fr
• Phone: (+33) 1 42 16 27 48

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.