Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)

Launched by RENNES UNIVERSITY HOSPITAL · Aug 10, 2016

Keywords

ClinConnect Summary

The EARLY-PUMP clinical trial is studying the use of an apomorphine pump for people with early-stage Parkinson's Disease (PD). This trial aims to find out if using the pump can improve patients' quality of life better than just taking oral medications when they first start to experience motor complications. The researchers believe that by starting this treatment earlier, patients can maintain their ability to socialize and work, which could lead to positive benefits for both individuals and the healthcare system.

To be eligible for this trial, participants need to be adults aged 65 or younger, have a confirmed diagnosis of Parkinson's Disease for at least four years, and experience certain difficulties in daily activities or social functioning due to their symptoms. They should also not have any significant mental health issues or other serious health problems that might complicate their participation. If someone joins the trial, they will receive the apomorphine pump and be closely monitored to see how it affects their symptoms and overall quality of life. It's important to note that this trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged ≤ 65 years,
• • Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of Parkinsonism,
• • Hoehn and Yahr stage ≤ 2.5 in the best ON,
• • Disease duration ≥ 4 years,
• • Presence of fluctuations and/or dyskinesias for no more than 3 years,
• * One of the two following forms of impairment :
• • Impairment in activities of daily living (MDS-UPDRS II\>6) due to PD-symptoms despite medical treatment in the worst condition or,
• • Impairment of social and occupational functioning (measured with SOFAS) due to PD-symptoms despite medical treatment (51-80%),
• • PDQ39 completed,
• • Able to understand and remember the component of the study,
• • Written informed consent,
• • Patients covered with social insurance.
• Exclusion Criteria:
• • Dementia (MoCA \< 22),
• • Major uncontrolled depression at the time of assessment (BDI \> 25) or Bipolar disease,
• • Active hallucinations or history of hallucinations in the past year,
• • Need for nursing care,
• • Previous use of apomorphine pump treatment,
• • History of respiratory depression,
• • History of deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa,
• • Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state,
• • Symptomatic clinically relevant and medically uncontrolled orthostatic hypotension,
• • Clinically relevant hepatic dysfunction (total bilirubin \>2.0 mg/dL, Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) \>2 times the upper limit of normal),
• • Clinically relevant renal dysfunction (serum creatinine \>2.0 mg/dL),
• • Pregnant and breastfeeding women,
• • Hypersensitivity to apomorphine or any excipients of the medicinal product,
• • Concomitant therapy or within 28 days prior to baseline with : alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except Clozapine), methylphenidate, or amphetamine, intrajejunal Ldopa,
• • History or current drug or alcohol abuse or dependencies,
• • Patients with a borderline QT interval corrected for heart rate according to Bazett's formula (QTc) of \>470 ms for male and \>480 ms for female at screening or history of long QT syndrome;
• • Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty.