STUDIES CURRENTLY
ENROLLING
Title:
A long-term, double-blind, randomized, parallel-group,
carbidopa/levodopa controlled, multi-center
study to evaluate the effect of Stalevo in patients with Parkinson’s disease
requiringinitiation of levodopa therapy
Purpose:
The purpose of this study is to demonstrate that used as
initial levodopa therapy, Stalevo
carbidopa/levodopa/entacapone) results in a significant
prolongation in the time to development of incident
dyskinesia when compared to standard formulation
carbidopa/levodopa in Parkinson’s disease.
Summary:
The trial consists of two phases: pre-randomization
(with screening and baseline periods) and the
double-
blind treatment phase (with dose titration and
maintenance periods).
Eligibility: Male or Female aged 30 to 70 years diagnosed with
idiopathic Parkinson’s disease for no more than 5 years
Modified
Hoehn and Yahr stage 1.0 – 2.5
PI:
Robert Hauser, MD
Contact: Holly Delgado
at (813) 844-4453
________________________________________________________________________
Title: A Multicenter, Double-Blind,
Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s
Disease Subjects
Purpose: The primary objective of this study is to assess rasagiline as
a disease modifying therapy in Parkinson’s disease.
Summary: This study will be comprised of 2 phases: phase I – a 36-week doubleblind,
placebo-controlled phase, and phase II – a 36-week double-blind, active-treatment phase.
After being found eligible to participate in the study, subjects will be allocated in a 1:1:1:1 ratio into one of the
following four treatment groups based on a randomization scheme with blocks stratified by centers:
1. 1 mg/day rasagiline
during phase I and phase II (1 mg early start)
2. 2 mg/day rasagiline
during phase I and phase II (2 mg early start)
3. placebo during phase
I followed by 1 mg/day rasagiline during phase
II (1 mg delayed start)
4. placebo during phase
I followed by 2 mg/day rasagiline during phase
II (2 mg delayed start)
Eligibility: Subjects must meet all the inclusion criteria to be eligible:
1. Men and women with idiopathic Parkinson’s
disease whose diagnosis is confirmed by the
presence of at least two of the cardinal signs (resting
tremor, bradykinesia, rigidity), without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
2. Subjects with a diagnosis
of early idiopathic PD of less than 1½ years duration from time of diagnosis.
3. Subjects whose clinical
condition at the time of study enrollment does not
require any anti-PD treatment and, to the best of the investigator’s judgment, will
not require for the next 9 months.
PI: Robert
Hauser, MD
Contact:
Diana Delaney at (813) 844-4477
________________________________________________________________________
Title: Study of the safety, tolerability and efficacy of Spheramine implanted bilaterally
into the post commissural putamen of patients with advanced Parkinson’s Disease
Purpose: The purpose of this study is to evaluate the safety, tolerability
and efficacy of bilateral intrastriatal Spheramine implants in patients with advanced Parkinson’s disease compared to
placebo.
Summary: All patients will undergo a series of pre-treatment evaluations over a 3-month period
by a neurologist to confirm optimization of antiparkinsonian medication and that subjects are candidates for the study according
to the inclusion and exclusion criteria. At the completion of the pre-treatment phase, eligible patients will be randomized
to receive either bilateral surgical implantation of Spheramine into the postcommissural putamen of the brain or a sham surgery
that does not enter the brain. The surgical procedures will be performed by a neurosurgeon located in a different city.
Following administration of Spheramine or sham surgery, subjects will return to their treating neurologist for evaluations
at scheduled intervals for 2 years. Spheramine patients will be followed annually thereafter for at least 5 years from receipt
of Spheramine.
Eligibility: Male or Female Patients aged 30-70 years with idiopathic
Parkinson’s Disease and symptoms for at least 5 years which are uncontrollable under optimum pharmacotherapy, yet responsive
to dopaminergic agents.
PI:
Robert Hauser,
MD
Contact:
Mary Hoskinson at (813) 844-8069
________________________________________________________________________
Title: Evaluation of the Efficacy
and Safety of ALTROPANE for differentiating parkinsonian syndromes from non-parkinsonian syndromes in patients with tremors
Purpose: The primary purpose of the study is to demonstrate the efficacy
of ALTROPANE in patients with tremor.
Summary: There will be a total of 3 visits. After completion of Visit 1 and confirmation of
baseline laboratory tests and ECG’s, Visit 2 (SPECT imaging) will be schedule within one month. Patients will return to the clinic 24 hours following ALTROPANE administration for scheduled safety assessments
at Visit 3.
Eligibility: Male or Female between the ages of 18 and 80 and diagnosed
by an Internist/General Practitioner as having or suspected of having tremors.
PI:
Robert Hauser,
MD
Contact:
Summer Wolfrath at (813) 844-4399
________________________________________________________________________
Title: A Phase 2, Double-Blind, Placebo-Controlled,
Randomized, Parallel-Group, Multicenter Study of the Efficacy and Safety of 40mg/day KW-6002 (Istradefylline) as Monotherapy
in Subjects with Parkinson’s Disease
Purpose: The purpose of this study is to evaluate the safety and efficacy
of 40mg/day of Istradefylline in the treatment of subjects with Parkinson’s disease.
Summary:
This study will last 12 weeks and the chance of placebo is 50%.
Eligibility: PD patients >= 30 years of age; Hoehn and Yahr stage 1-2.5; must not have taken sinemet longer
than 1 month; wash off all dopamine agonists/antagonists 30 days prior to study screening; no cancers within 5 years of study
PI:
Robert Hauser, MD
Contact:
Diana Delaney at (813)844-4477
________________________________________________________________________
Title: A Phase 2, Double-Blind, Placebo-Controlled,
Randomized, Parallel-Group, Multicenter, Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) in
Subjects with Restless Legs Syndrome
Purpose: The purpose of this study is to test the safety and efficacy of
40 mg/day of istradefylline in patients with Restless Legs Syndrome.
Summary: This is an 8 week study where exposure to study drug will be 6 weeks. The chance of placebo is 50%.
Eligibility: Males and females age 18 and older; have RLS symptoms
at least 15 nights in the previous month; willing to wash off all RLS medications for 2 weeks prior to screening; must not
use iron supplements; have not had cancer in previous 5 years
PI:
Robert Hauser, MD
Contact:
JoAnne Nemeth at (813)844-8068
________________________________________________________________________
Title: Prospective double blind evaluation
of levetiracetam (Keppra) for the treatment of cervical dystonia
Purpose: To determine if there is an improved response in CD symptoms when
Keppra is used as adjunctive therapy to Botox
Summary: Patients will be evaluated at baseline 12-16 weeks following their prior set of Botox
injections. Patients will be evaluated using the TWSTRS Cervical Dystonia Scale. Any oral medications for the treatment of
cervical dystonia will be stable for at least four weeks and will continue unchanged throughout the study. Following Baseline
evaluation, subjects will undergo their standard set of Botox injections. This will consist of the same dose and approximate
placement as their prior set of injections. Subjects will then be randomized to LEV or placebo. They will begin oral study
medication beginning with an LEV dose of 250 mg each evening or placebo. There will be flexible dose titration increasing
by 250 mg per week for 12 weeks to a maximum of 3000 mg divided BID. The subjects will be on a stable dose of medication for
weeks 12 to 16 (or to week 20 in subjects with sufficient improvement that they do not require Botox injections). Subjects
will be evaluated at weeks 4,8,12, 16, 20 and 24
Eligibility: Male or female patient at least 18 years of age. Patient has a diagnosis of cervical dystonia and will have been treated with Botox
injections. Oral medications for the treatment of cervical dystonia stable for at least four weeks. Patient has been treated with Botox injections within the past 12-16 weeks.
PI:
Robert Hauser,
MD
Contact:
Mary Hoskinson at (813) 844-8069
________________________________________________________________________
Title:
Glutathione
(GSH) in The Treatment of Parkinson’s disease
Purpose: The purpose of this study is to determine if intravenous Glutathione
(GSH) is helpful and safe in treating the symptoms of Parkinson’s disease.
Summary: This is a 12 week study: 3 visits/week for 4 weeks, then follow up at weeks 8 and
12. Chance of placebo is 50%
Eligibility: To be eligible for this study, patients must have:
Idiopathic
Parkinson’s disease (2 of 3 of the cardinal symptoms, tremor, bradykinesia, rigidity)
Mini Mental State Examination
> 24
Anti-parkinsonian medications stable for one month
Hoehn and Yahr II-IV
PI:
Robert Hauser, MD
Contact:
Diana Delaney at (813) 844-4477
________________________________________________________________________
Title: Study of Environmental Association
and Risk of Parkinsonism using Case-Control Historical Interviews (SEARCH)
Purpose: The long-term goal is to determine the relative contributions of
genetic and environmental factors in the etiology of Parkinson’s disease (PD) and parkinsonism, specifically those that
relate to occupation.
Summary: Cases will be consented in the office and the Parkinson’s Institute will contact
the patient to set up a phone interview. They will undergo testing in the
office that consists of vital signs, a motor exam, evaluation by the Movement Disorders Specialist, and voluntary blood test. Controls will be sent home with information and will call the Parkinson’s Institute
to set up a phone interview. Phone interviews will last up to 3 hours, but can
be done in a series of several calls. All participants will be paid $50 for their
time.
Eligibility: Cases must be patients with a diagnosis of PD for less
than 5 years; must be able to speak and hear English, and have no dementia. Controls
must be non-blood relatives of cases.
PI:
Robert Hauser, MD
Contact:
Diana Delaney at (813) 844-4477
________________________________________________________________________
Title: Safety and Efficacy of Melperone
in the Treatment of Patients with Psychosis Associated with Parkinson’s Disease
Purpose: The primary objective of this study is to test the safety and efficacy
of 20, 40, and 60 mg per day of melperone syrup in subjects with pschosis associated with Parkinson's Disease.
Summary: There will be 7 office visits and 2
phone calls over a 10 week study period. Qualified subjects will be randomized
to one of four treatment groups: 20, 40, 60 mg per day of melperone syrup OR
placebo.
Eligibility: Subjects must have 3 cardinal signs of PD; must have
psychosis; MMSE > 21; on stable medications; no serious cardiac history.
PI:
Robert Hauser, MD
Contact:
Holly Delgado at (813)844-4453
________________________________________________________________________
Title: Parkinson’s Research:
The Organized Genetics Initiative (PROGENI)
Purpose: The purpose of this study is to identify the gene(s), which predispose
individuals to develop Parkinson’s disease.
Summary: To study genetic and other risk factors which may be important in the development
of Parkinson’s disease.
Eligibility: Those with a diagnosis of Parkinson’s disease and
who have a sibling also
diagnosed with or suspected of having Parkinson’s Disease.
PI:
Robert Hauser,
MD
Contact:
Summer Wolfrath at (813) 844-4399
