Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0 Level: LLT Classification code 10034006 Term: Parkinson's disease aggravated System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: Apomorphine hydrochloride
CAS Nu
Sponsors
Britannia Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients aged =30 - Diagnosis of idiopathic Parkinson’s disease of >3 years’ duration, defined by the UK Brain Bank criteria (with the exception of >1 affected relative being allowed), without any other known or suspected cause of Parkinsonism - Hoehn & Yahr stage up to 3 in the ON and 2 to 5 in the OFF state - Motor fluctuations not adequately controlled on medical treatment including L-dopa which was judged to be optimal by the treating physician - Average of OFF time>= 3 h/day based on screening and baseline diary entries with no day with =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: -History of respiratory depression - Hypersensitivity to apomorphine or any excipients of the medicinal product - High suspicion of other parkinsonian syndromes - Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state - Concomitant therapy or within 28 days prior to baseline with: apomorphine pen injections, alpha-methyl dopa, metoclopramide, reserpine, neuroleptics, methylphenidate, or amphetamine; intrajejunal L-dopa - Previous use of apomorphine pump treatment - History of deep brain stimulation or lesional surgery for PD - Any medical condition that is likely to interfere with an adequate participation in the study, including e.g. current diagnosis of unstable epilepsy; clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months - Symptomatic, clinically relevant and medically uncontrolled orthostatic hypotension - Patients with a borderline QT interval corrected for heart rate according to Bazett’s formula (QTc) of >450 ms for male and >470 ms for female at Screening or history of long QT syndrome; or >450 ms absolute duration - Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, ALT and AST >2 times the upper limit of normal) - Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL); - Pregnant and breastfeeding women - Clinically relevant cognitive decline, defined as MMSE =24 or according to DSM IV criteria for dementia - Active psychosis or history of at least moderate psychosis in the past year, or with medically uncontrolled severe depression; very mild illusions or hallucinations in the sense of “feelings of passage or presence” with fully retained insight are not an exclusion criterion - Known history of melanoma - Any investigational therapy in the 4 weeks prior to randomization - History or current drug or alcohol abuse or dependencies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: After 12 weeks of treatment;Main Objective: The primary objective is to investigate the efficacy of apomorphine subcutaneous infusion compared to placebo in PD patients with motor fluctuations not well controlled on medical treatment.;Secondary Objective: To investigate the safety and tolerability of apomorphine subcutaneous infusion therapy.;Primary end point(s): Primary efficacy variable is the absolute change in time spent “OFF” from baseline to the end of 12 weeks double-blind treatment period based on patient diaries. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients with response to therapy, defined as an OFF-time reduction of at least 2 hours, from baseline to end of 12 weeks double-blind treatment period - Patient Global Impression of Change - Absolute change in time spent “ON” without troublesome dyskinesia” - Change in oral L-dopa and L-dopa equivalent dose - Change in Unified Parkinson’s Disease Rating Scale (UPDRS Part III motor examination) during ON periods - Change in Quality of Life (using PDQ-8);Timepoint(s) of evaluation of this end point: After 12 weeks of treatment | — |
Countries
Austria, Denmark, France, Germany, Netherlands, Spain
Contacts
Public ContactClinical Operations
AMS Advanced Medical Services GmbH
Outcome results
None listed