Studies
at the Parkinson's And Movement Disorder Institute-
Dr. Daniel Truong
Study #1
PARKINSON’S DISEASE
If you have Parkinson's disease and have motor fluctuations with recurrent
episodes of difficulty moving around, you may be qualified to participate
in a clinical research study. The intent of this study is to evaluate
the effectiveness of an investigational drug in the treatment of Parkinson's
disease.
Qualified participants receive study related care at no charge.
For information, please contact Dr. Daniel Truong at: The Parkinson's
and Movement Disorder Institute, Tel: (562) 989-7997 (Long Beach) or (714)
378-5062 (Orange County)
Check our website: www.pmdi.org
Study #2
PARKINSON’S DISEASE
If you have Parkinson's disease and also have abnormal involuntary movements
or difficulty to move before the next dose of Parkinson's drug,
you may be qualified to participate in a clinical research study. Qualified
participants receive study related care at no charge. For information,
please contact Dr. Daniel Truong at the
The Parkinson's and Movement Disorder Institute (PMDI). Tel: (562) 989-7997
(Long Beach) or (714) 378-5062 (Orange County). Check our website: www.pmdi.org
Study #3
PARKINSON’S STUDY
If you have Parkinson's disease and currently not on any dopamine agonist,
you may be qualified to participate in a clinical research study investigating
a dopamine agonist patch on the skin for Parkinson's disease. Qualified
participants receive study related care at no charge. For information,
please contact The Parkinson's and Movement Disorder Institute. Tel: (562)
989-7997 (Long Beach) or (714) 378-5062 (Orange County). Check our website:
www.pmdi.org
Study #4
PARKINSON’S STUDY
Symptoms of Parkinson's disease consist of tremor, stiffness and slowness.
If you think you have Parkinson's disease and have not taken any Parkinson's
medication, you may be qualified to participate in a clinical research
study. The intent of this study is to examine the relationship of L-DOPA
and the progression of Parkinson's disease. Qualified participants
receive study related care at no charge. For information, please contact
Daniel Truong, M.D. at The Parkinson's and Movement Disorder Institute
Orange Coast Memorial Medical Center. Tel: (562) 989-7997 (Long Beach)
or (714) 378-5062 (Orange County). Check our website: www.pmdi.org
Study #5
Parkinson's Research: The Organized Genetics Initiative (PROGENI)
We seek to identify and recruit pairs of siblings affected with Parkinson's
disease (PD). The intent of the study is to clarify possible environmental
factors and search for genetic factors that may play a role in the development
of PD.
Individuals who are willing to participate in this study must have one
or more living sibling(s) affected with, or suspected of having, PD.
If you think you qualify, please contact Daniel Truong, M.D. at
The Parkinson's and Movement Disorder Institute Orange Coast Memorial
Medical Center. Tel: (562) 989-7997 (Long Beach) or (714) 378-5062 (Orange
County)
Check our website: www.pmdi.org
Study #6
PARKINSON’S STUDY (Research Study of Wryneck)
Torticollis is a movement disorder resulting in forced turning of the
head to one side. If you have torticollis, you may be qualified
to participate in a clinical research study using an investigational drug
to relax the involuntary contracted muscles. Qualified participants receive
study related care at no charge. For information, please contact: The
Parkinson's and Movement Disorder Institute
Tel: (562) 989-7997 (Long Beach) or (714) 378-5062 (Orange County)
Check our website: www.pmdi.org
Study #7
SPASTICITY AFTER STROKE
After a stroke, some patients may develop localized spasticity, resulting
in muscle tightness. If you have these symptoms you may be able
to participate in a study evaluating the effect of an investigational
drug on patient with spasticity.
Qualified participants receive study related care at no charge.
For information, please contact. PMDI. The Parkinson's and Movement Disorder
Institute
Tel: (714) 378-5062 (Fountain Valley) or (949) 462-0396 (Laguna Hills)
or (562) 989-7997 (Long Beach). Visit our website: www.pmdi.org
Summary of Study # 4 THE ELLDOPA STUDY
EARLIER VS. LATER L-DOPA IN PARKINSON�S DISEASE
The study is a multicenter, double blind clinical trial in outpatients.
It is designed to determine whether earlier vs. later introduction (and
moderate vs. low dosage) of Levodopa to patients with Parkinson's disease
is beneficial or harmful. It is intended to answer the concern raised
by clinicians and patients regarding Parkinson's disease (PD), namely,
should the introduction of L-dopa be delayed as long as clinically feasible
or should it be employed early to improve quality of life.
Levodopa is considered the "gold standard" of symptomatic therapy because
it is the most effective drug in controlling parkinsonian symptoms.
However, there is uncertainty about whether it may be harmful in the long
run. First, because of concerns that its metabolites might increase
oxidant stress and thereby hasten progression of Parkinson's disease,
and second, because it might lead to earlier introduction of clinical
fluctuations of motor response and unpleasant dyskinesias.
The initial study visit consists of screening tests, medical history,
and physical examination. Patients meeting the inclusion/exclusion criteria
and screening test requirements of the protocol will be randomized to
receive either active study drug or placebo and will be seen weekly during
the treatment phase. All study medications, office visits, physical examinations,
screening and laboratory tests are provided.
Inclusion/Exclusion Criteria
A. Inclusion Criteria
1. The presence of idiopathic Parkinson's disease, with at
least two of the following three cardinal signs (resting tremor, bradykinesia,
rigidity) being present, and without any other known or suspected cause
of parkinsonism.
2. Adults, 30 years or older, with onset of symptom after
the age of 29. Both men and women in all ethnic groups are eligible to
participate. Women of child-bearing age will not be excluded.
3. Parkinson's rating scale 1, 1.5, 2.0, or 2.5, representing
the stage of unilateral involvement (stage 1.0 and 1.5) and mild bilateral
or mid line involvement without impairment of balance (Stage 2.0 and 2.5).
4. Duration from time of diagnosis < 2 years.
B. Exclusion Criteria
1. Those with an identifiable cause of Parkinsonism by history,
examination, or laboratory testing. Specifically there will be no history
of multiple strokes, encephalitis, oculogyric crisis, remission, or exposure
to toxicants or to recent neuroleptics. Patients with supranuclear
gaze paresis, extensor plantar responses, cerebellar signs, dementia (score
of 25 or lower out of 30 on the minimental state test, or symptomatic
or prominent orthostatic hypotension (mean arterial pressure drop >25
mm Hg on standing) will be excluded. Exposure to neuroleptics for
non-psychotic usage (e.g. metoclopramide for gastrointestinal problems)
without persistent extrapyramidal sequelae would not exclude patients
if the interval between exposure and enrollment was greater than 6 months.
2. Those with a UPDRS tremor score in any limb of 3.0 severity
or greater.
3. The presence of either freezing (motor blocks) or loss
of postural reflexes.
4. Those taking or requiring any antiparkinson medications
and patients expected (by the investigator) to require symptomatic antiparkinsonian
therapy within 6 months.
5. Prior exposure to any levodopa preparation or dopamine
agonist.
6. Prior exposure to amantadine, anticholinergics and antihistamines
is permitted within one month prior to entry into the study.
7. Exposure to selegiline or other irreversible monoamine
oxidase inhibitors within 4 months of enrollment.
8. Exposure to dopamine receptor blocking agent, including
calcium channel blockers, cinnarizine and flunarizine within the past
6 months of enrollment.
9. Unstable medical condition or history of drug abuse.
10. Major depression (Halmilton score > 19)
Those with a medical history of medical malignant melanoma
Copyright © 2006. www.pmdi.org
Last update: January 18, 2006
Daniel Truong, M.D.
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