2016-05-26
Summary
This is a multicenter,
randomized, double blind, placebo controlled parallel group clinical study.
Following a screening period of up to 28 days, eligible subjects will be
randomized to receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase
Inhibitor) with continuous subcutaneous infusion of ND0612 or matching placebo
for 16 weeks.
Description
This LGfEGNT2Lhmphase
III randomized, double-blind, placebo controlled, parallel group
clinical study will be conducted in 150 subjects with idiopathic PD who are
experiencing motor complications despite optimized anti-PD therapy.
The study will investigate the
efficacy, safety and tolerability of continuous SC infusion (16 weeks) of
ND0612 compared with placebo infusion. The treatment period will be comprised
of a 4-week adjustment period during which time the ND0612 infusion dose will
remain constant and the oral LD/DDI dose can be decreased or increased back up
to the Baseline levels. All other anti-PD treatments must remain constant.
During the maintenance period (Weeks 5 to 16) all anti-PD LGfEGNT2Lhmmedication
including the ND0612/placebo should remain constant.
Study
Design
Allocation: Randomized,
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel
Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes
Assessor), Primary Purpose: Treatment
Conditions
LGfEGNT2LhmParkinson's
Disease
Intervention
ND0612, ND0612 Placebo
Status
Not yet recruiting
Source
NeuroDerm Ltd.
Results
(where available)
Links
Published on BioPortfolio:
2016-05-26T12:53:21-0400
Clinical
Trials
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Medical
and Biotech [MESH] Definitions
Mptp Poisoning
A condition caused by the
neurotoxin MPTP which causes selective destruction of nigrostriatal
dopaminergic neurons. Clinical features include irreversible parkinsonian signs
including rigidity and bradykinesia (PARKINSON DISEASE, SECONDARY). MPTP
toxicity is also used as an animal model for the study of PARKINSON DISEASE.
(Adams et al., Principles of Neurology, 6th ed, p1072; Neurology 1986
Feb;36(2):250-8)
Parkinsonian Disorders
A group of disorders which
feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY;
TREMOR; and postural instability. Parkinsonian diseases are generally divided
into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see
PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are
associated with dysfunction of dopaminergic or closely related motor
integration neuronal pathways in the BASAL GANGLIA.
Parkinson Disease, Postencephalitic
Parkinsonism following
encephalitis, historically seen as a sequella of encephalitis lethargica (Von
Economo Encephalitis). The early age of onset, the rapid progression of
symptoms followed by stabilization, and the presence of a variety of other
neurological disorders (e.g., sociopathic behavior; TICS; MUSCLE SPASMS;
oculogyric crises; hyperphagia; and bizarre movements) distinguish this
condition from primary PARKINSON DISEASE. Pathologic features include neuronal
loss and gliosis concentrated in the MESENCEPHALON; SUBTHALAMUS; and
HYPOTHALAMUS. (From Adams et al., Principles of Neurology, 6th ed, p754)
Parkinson Disease, Secondary
Conditions which feature
clinical manifestations resembling primary Parkinson disease that are caused by
a known or suspected condition. Examples include parkinsonism caused by
vascular injury, drugs, trauma, toxin exposure, neoplasms, infections and
degenerative or hereditary conditions. Clinical features may include
bradykinesia, rigidity, parkinsonian gait, and masked facies. In general,
tremor is less prominent in secondary parkinsonism than in the primary form.
(From Joynt, Clinical Neurology, 1998, Ch38, pp39-42)
Selegiline
A selective, irreversible
inhibitor of Type B monoamine oxidase. It is used in newly diagnosed patients
with Parkinson's disease. It may slow progression of the clinical disease and
delay the requirement for levodopa therapy. It also may be given with levodopa
upon onset of disability. (From AMA Drug Evaluations Annual, 1994, p385) The
compound without isomeric designation is Deprenyl.
More
From BioPortfolio on "A Clinical Study Investigating the Efficacy,
Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as
Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With
Motor Fluctuations"
http://www.bioportfolio.com/resources/trial/158733/A-Clinical-Study-Investigating-the-Efficacy-Tolerability-and-Safety-of-Continuous-Subcutaneous.html
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