Use and Misuse of Domperidone in Parkinson's Disease in France - Observational

NCT04653584 | Terminated

• 1 other identifier: DUMP-obs
• Study Type: observational
• Target: 1,579
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson disease is the second most frequent neurodegenerative disease after Alzheimer disease and affect 1% of the population over 60 years. The treatment of PD is based on dopamine replacement therapies (DRT). Nausea is the most frequent adverse event whatever the drug, occurring in 30-40% of patients at the initiation of DRT. Domperidone, a dopamine D2 receptor antagonist with antiemetic properties, does not readily cross the blood-brain barrier, allowing its used in PD. Domperidone may prolong the duration of the QT interval in predisposed patients, and has been associated with proarrhythmia and arrhythmic deaths. Arrhythmias, sudden death and cardiac arrest were reported with high intravenous doses which has led to withdraw of the parenteral form of the drug in 1984. Two case control studies found an increased risk of sudden death associated with domperidone use. In these reports, the increased risk was depending on age, dose, and the use of domperidone in combination with CYP3A4 inhibitors. Following the discussion created by this alert, the PRAC of the EMA has issued recommendations restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for a short period (7 days). Because there is no alternative antiemetic drug to be used in PD, domperidone is commonly prescribed as a preventive therapy in most PD patients initiating DRT. In this population, usually older than 60 years, doses of 60 or 80 mg/day are commonly prescribed, for at least 2 months of the DRT escalating dose period or longer. A particular "niche" of domperidone misuse might be patients treated with continuous subcutaneous administration of apomorphine, a second line therapy in PD, inducing severe and prolonged nausea in almost all patients. Little is known about the use of domperidone in PD in France, but misuse of domperidone in PD patients is probably very high. Data collected from two French PD cohorts, COPARK and DIGPD, showed that 8-14% of PD patients were treated with domperidone. The aim of this proposal is to conduct a cross sectional observational study performed in consecutive patients followed by the 24 PD expert centers of the NS Park network, general hospitals and private practice neurologists, to describe the actual use of domperidone in PD patients.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of Parkinson Disease patients treated by domperidone in misuse conditions regarding the recommendation

  Inclusion visit, day 1

Secondary Outcomes (7)

• Daily dosage of domperidone

  Inclusion visit, day 1

• Duration of treatment with domperidone

  Inclusion visit, day 1

• Indications for the prescription of domperidone

  Inclusion visit, day 1

• Safety measures taken before domperidone prescription in PD patients : ECG (before and after the prescription of domperidone), consultation with a cardiologist and other safety measures

  Inclusion visit, day 1

• Use of domperidone in combination with contraindicated drugs indicated with domperidone or at risk of contraindicated drug interactions

  Inclusion visit, day 1

Study Arms (3)

1

Parkinson Disease patients treated by domperidone according the recommendation

2

Parkinson Disease patients treated by domperidone in misuse conditions regarding the recommendation

3

Parkinson Disease patients without treathment by domperidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of Parkinson's disease according to the UKPDSBB criteria

You may qualify if:

• All consecutive patients with a diagnosis of Parkinson's disease according to the UKPDSBB criteria and followed-up in consultation or hospitalization in the participating centers

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

La Pitié Salpétrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: December 4, 2020
• Study Start: January 1, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: March 15, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodological sound proposal

Locations

FR (1)