Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT02864004
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02864004
Study Brief:
Protocol Section:
NCT02864004