Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02006121 : Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease
PhasePhase 3
AgesMin: 30 Years Max: N/A
Eligibility
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 < 2 hours of OFF time recorded

- Stable medication regimen, with a stable dose of L-dopa administered in at least 4
intakes, for at least 28 days prior to baseline. All oral or transdermal
antiparkinsonian drugs are permitted, with the exception of budipine. This regimen
may include the use of L-dopa /DDCI rescue medication if this occurs up to 2 times a
day, at doses of up to 200 mg L-dopa/day

- Patients must be able to differentiate between the ON and OFF state and between
troublesome and non-troublesome dyskinesias

- Male and female patients must be compliant with a highly effective contraceptive
method (oral hormonal contraception alone is not considered highly effective and must
be used in combination with a barrier method) during the study and for 9 months
long-term follow-up period, if sexually active

- Females of childbearing potential must have a negative serum hCG pregnancy test at
screening

- Ability to accurately complete a paper diary on designated days (with assistance from
caregivers, if required), recording periods when they are "ON without troublesome
dyskinesia", "ON with troublesome dyskinesia", OFF, and sleeping

- Written informed consent prior to enrolment, after being provided with detailed
information about the nature, risks, and scope of the clinical trial as well as the
expected desirable and adverse effects of the study treatments

- Patients considered reliable and capable of adhering to the protocol, visit schedule,
and medication intake according to the judgment of the investigator

Exclusion Criteria:

- 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02006121      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740