Research and Clinical Trials
STUDIES CURRENTLY ENROLLING
A long-term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinso's disease requiring initiation of levodopa therapy
Title:
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.
Purpose:
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)
Summary:
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
Eligibility:
Robert Hauser, MD
PI:
Holly Delgado at (813)844-4453
Contact:
Study of the safety, tolerability and efficacy of Spheramine implanted bilaterally into the post commissural putamen of patients with advanced Parkinson's Disease
Title:
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.
Purpose:
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.
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.
Summary:
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.
Eligibility:
Robert Hauser, MD
PI:
Mary Hoskinson at (813)844-8069
Contact:
A 12 Week Double-blind, Placebo-controlled Study to Assess the Tolerability, Efficacy and Safety of Ropinirole Dosed PRN in Subjects with Restless Legs (RLS) who Respond to Open-Label Treatment with Ropinirole. (TREAT RLS PRN)
Title:
To compare the efficacy of a PRN dosing regimen of ropinirole and placebo in the treatment of subjects with RLS.
Purpose:
The study will last from 18-20 weeks and will consist of:
1. A 2-4 week Screening/washout period.
2. A 3 week Open-Label Phase.
3. A 12-week, Double-Blind Treatment Phase. Only subjects who complet the Open-Label Phase and for whom 0.5mg ropinirole is well-tolerated and effective PRN dose will be randomized to double-blind treatment to either 0.5mg ropinirole or matching placebo
4. A 1 week Follow up period
Summary:
Male or Female aged 18 and less than 80 and diagnosed with RLS using International RLS Study Group (IRLSSG) diagnostic criteria.
Eligibility:
Robert Hauser, MD
PI:
Holly Delgado at (813)844-4453
Contact:
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
Title:
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.
Purpose:
This study will last 12 weeks and the chance of placebo is 50%.
Summary:
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
Eligibility:
Robert Hauser, MD
PI:
Summer Wolfrath at (813) 844-4399
Contact:
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
Title:
The purpose of this study is to test the safety and efficacy of 40 mg/day of istradefylline in patients with Restless Legs Syndrome.
Purpose:
This is an 8 week study where exposure to study drug will be 6 weeks. The chance of placebo is 50%.
Summary:
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
Eligibility:
Robert Hauser, MD
PI:
JoAnne Nemeth at (813) 844-8068
Contact:
A 12 Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome
Title:
To compare the safety and efficacy of ropinirole XR and placebo in adult patients with RLS requiring early evening and nighttime coverage of RLS symptoms.
Purpose:
Following the washout/screening phase, eligible patients will enter a 12 week flexible dose treatment phase. The chance of placebo is 50%, where the dose range is 0.5mg/day to 6.0mg/day. Study visits will occur at Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12.
Summary:
Patients between the ages of 18 and 80; must have a minimum of 20 evening and nights of RLS episodes during month prior to screening visit; RLS symptoms must cause severe/very severe sleep disturbance; must not be experiencing RLS symptoms earlier than 5pm; must not require daytime treatment of RLS; must not have diagnosis of sleep disorder or other movement disorder; must not be taking medication that causes drowsiness
Eligibility:
Robert Hauser, MD
PI:
Diana Delaney at (813) 844-4477
Contact:
Glutathione (GSH) in The Treatment of Parkinson's disease
Title:
The purpose of this study is to determine if intravenous Glutathione (GSH) is helpful and safe in treating the symptoms of Parkinson's disease.
Purpose:
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%
Summary:
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
Eligibility:
Robert Hauser, MD
PI:
Diana Delaney at (813) 844-4477
Contact:
A two year Phase IIIb randomised, multicenter, double-blind, Sinemet-controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects.
Title:
The purpose of this study is to evaluate the time to onset of dyskinesia over two years of treatment with controlled release Ropinirole, compared with Sinemet in patients who are already being treated with levodopa with sub-optimal benefit.
Purpose:
The patients will have minimally 15 visits over the 107 week (2 years and 3 weeks) duration of the study. Screened patients will be randomised to double blind treatment of either add on ropinirole CR or Sinemet.
Summary:
Men or women aged 30-70 with a diagnosis of idiopathic Parkinson's Disease and demonstrating a lack of control with L-dopa therapy Patients on 600mg or less of L-dopa for 3 years or less
Eligibility:
Robert Hauser, MD
PI:
Diana Delaney at (813) 844-4477
Contact:
Evaluation of the Efficacy and Safety of ALTROPANE for differentiating parkinsonian syndromes from non-parkinsonian syndromes in patients with tremors
Title:
The primary purpose of the study is to demonstrate the efficacy of ALTROPANE in patients with tremor.
Purpose:
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.
Summary:
Male or Female between the ages of 18 and 80 and diagnosed by an Internist/General Practitioner as having or suspected of having tremors.
Eligibility:
Robert Hauser, MD
PI:
Summer Wolfrath at (813) 844-4399
Contact:
A two year Phase IIIb randomised, multicenter, double-blind, Sinemet-controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects.
Title:
The purpose of this study is to evaluate the time to onset of dyskinesia over two years of treatment with controlled release Ropinirole, compared with Sinemet in patients who are already being treated with levodopa with sub-optimal benefit.
Purpose:
The patients will have minimally 15 visits over the 107 week (2 years and 3 weeks) duration of the study. Screened patients will be randomised to double blind treatment of either add on ropinirole CR or Sinemet.
Summary:
Men or women aged 30-70 with a diagnosis of idiopathic Parkinson's Disease and demonstrating a lack of control with L-dopa therapy Patients on 600mg or less of L-dopa for 3 years or less
Eligibility:
Robert Hauser, MD
PI:
Diana Delaney at (813) 844-4477
Contact:
ACP-103 to Treat Parkinson's Disease
Title:
This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson's disease.
Purpose:
Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or changes in their condition. They also have an infusion of levodopa (see above) at the previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours. At the end of the infusions and ratings, patients are discharged home with their regular Parkinson's medications until the following visit.
Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.
Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.
Summary:
Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and 80 years of age
Eligibility:
Robert Hauser, MD
PI:
Holly Delgago at (813) 844-4453
Contact:
Parkinson's Research: The Organized Genetics Initiative (PROGENI)
Title:
The purpose of this study is to identify the gene(s), which predispose individuals to develop Parkinson's disease.
Purpose:
To study genetic and other risk factors which may be important in the development of Parkinson's disease.
Summary:
Those with a diagnosis of Parkinson's disease and who have a sibling also diagnosed with or suspected of having Parkinson's Disease.
Eligibility:
Robert Hauser, MD
PI:
Summer Wolfrath at (813) 844-4399
Contact:
A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR versus Ropinirole in Early Parkinson's Disease Patients.
Title:
The purpose of this study is to test your eyesight and your ability to see different lights and colors, to test your side vision and to measure the electrical response of your eye and your brain to different test lights while you are taking your Parkinson's disease medication.
Purpose:
This study will look at two Parkinson's disease (PD) medications in patients with early PD. The two medications that will be studied are pramipexole (also called Mirapex®) and ropinirole (also called Requip®). Both medications were approved in 1997 by the U.S. Food and Drug Administration (FDA) to treat the signs and symptoms of PD. Both medications are dopamine agonists (drugs that stimulate the parts of the brain that receive dopamine, an important substance that carries signals between nerve cells).
Summary:
Patients with idiopathic Parkinson's disease of <7 years duration; Maximum of 3 months cumulative lifetime exposure to dopaminergic therapy (i.e. levodopa and/or dopamine agonist); Age 30 years old; No previous history of allergic response or complications with any dopaminergic drugs (e.g., pramipexole, ropinirole or its excipients); No malignant melanoma or history of previously treated malignant melanoma; may not have received any of the following drugs:
• Neuroleptics, metoclopramide, alpha methyldopa, flunarizine, methylphenidate, cinnarizine, reserpine, or amphetamine derivative, within the past 6 months.
• Monoamine oxidase (MAO) inhibitors other than selegiline in the past 3 months.
• Beta-blockers (e.g., propranolol) to treat PD in the past 30 days. (Beta blockers for other conditions are permitted).
• Prior use of any drug which is known to have potential retino-toxic effects in the past 12 months (e.g., chloroquine, hydroxychloroquine, phenothiazines, tamoxifen).
• Use of Coenzyme Q10 in the past 14 days.
No history of glaucoma with or without treatment; no inherited or acquired retinopathy that may confound the outcome of the study (e.g., age-related macular degeneration, diabetic retinopathy, retinitis pigmentosa, color blindness, etc.); no diabetes mellitus; able to dilate pupils.
• Neuroleptics, metoclopramide, alpha methyldopa, flunarizine, methylphenidate, cinnarizine, reserpine, or amphetamine derivative, within the past 6 months.
• Monoamine oxidase (MAO) inhibitors other than selegiline in the past 3 months.
• Beta-blockers (e.g., propranolol) to treat PD in the past 30 days. (Beta blockers for other conditions are permitted).
• Prior use of any drug which is known to have potential retino-toxic effects in the past 12 months (e.g., chloroquine, hydroxychloroquine, phenothiazines, tamoxifen).
• Use of Coenzyme Q10 in the past 14 days.
No history of glaucoma with or without treatment; no inherited or acquired retinopathy that may confound the outcome of the study (e.g., age-related macular degeneration, diabetic retinopathy, retinitis pigmentosa, color blindness, etc.); no diabetes mellitus; able to dilate pupils.
Eligibility:
Theresa Zesiewicz, MD
PI:
Kelly Sullivan, MSPH at (813) 974-5909
Contact:
A two year Phase IIIb randomised, multicenter, double-blind, Sinemet-controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects.
Title:
The purpose of the study is to investigate the time to onset of dyskinesia (abnormal twisting, writhing movements) in Parkinson's Disease patients treated with either L-dopa and Ropinirole controlled release formulation or L-dopa and Sinemet, which are drugs used to help control symptoms associated with Parkinson's Disease.
Purpose:
30 – 70 years of age; Lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations); Patients on 600mg or less of L-dopa therapy for three years or less; Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening; No dyskinesia; No significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson's disease), or cardiovascular disease or active malignancy (other than basal cell cancer); No severe dizziness or fainting due to postural hypotension on standing; No Dementia; No recent history or current evidence of alcohol or drug abuse; No use of monoamine oxidase (MAO) inhibitors within three weeks of the screening visit except for the selective MAO-B inhibitor, Selegiline; No personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole CR; No withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment.
Eligibility:
Theresa Zesiewicz, MD
PI:
Kelly Sullivan, MSPH (813) 974-5909
Contact: