2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD
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ClinicalTrials.gov Identifier: NCT00209508 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: November 7, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Drug: GPI 1485 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 2-Year Study To Evaluate The Effects Of GPI 1485 On [123I]b-CIT/SPECT Scanning And Clinical Efficacy In Symptomatic PD Patients Receiving Dopamine Agonist Therapy. |
Study Start Date : | November 2002 |
Actual Study Completion Date : | October 2005 |

- To evaluate the efficacy of GPI 1485 vs. placebo on the percent change from baseline in [123I]ß-CIT/SPECT striatal uptake over 2 years in patients with idiopathic PD.
- To evaluate the efficacy of GPI 1485 vs. placebo in the treatment of symptomatic idiopathic PD patients using the following prespecified clinical measures of greatest interest:
- Mean daily L-Dopa Therapy Equivalents
- UPDRS ('On')
- Measures of sleep
- Cognitive function
- To evaluate the efficacy of GPI 1485 versus placebo using the following other acceptable measures of clinical assessment.
- To evaluate the efficacy of GPI 1485 versus placebo on the percent change from baseline in [123I]ß-CIT/SPECT putamen and caudate uptake over 2 years in patients with idiopathic PD.

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female patients 40 - 80 years of age with a diagnosis of idiopathic PD < 10 years. The diagnosis of idiopathic PD will be based on the medical history, neurologic examination, current response to anti-PD medication(s), and the presence of at least two of the following at the time of diagnosis: resting tremor, bradykinesia, or rigidity.
- Females must be postmenopausal for >= 12 months, surgically sterile, or agree to use acceptable forms of contraception. A negative serum pregnancy test must be confirmed prior to first dose for women of childbearing potential.
- Clinical diagnosis of idiopathic mild to moderate PD characterized by a Hoehn and Yahr rating of 1 to 3 in the 'Off' state (measured before the first dose of anti-PD medications on the day of assessment).
- UPDRS Motor 'Off' rating of 8-30 (measured before the first dose of anti-PD medications on the day of assessment).
- Mini-Mental Status Examination (MMSE) score of <= 25.
- Currently treated with an optimized dose of a dopamine agonist (stable dose for >= 1 month prior to randomization and treatment is optimized in the opinion of the Investigator).
- In the judgment of the Investigator the patient will not require L-Dopa therapy within the 3 months after randomization.
- Concomitant therapy with amantadine, selegiline, or anticholinergics is permitted, but not required. If the patient is treated with any of these medications the dose of this medication must be judged optimal and stable for > 1 month prior to randomization.
Exclusion Criteria:
- Presence of motor fluctuations including drug-induced dyskinesia, but excluding the pre-dose 'Off' state (prior to the first dose of anti-parkinsonian medication(s) on the day of assessment).
- History of surgical treatment of PD.
- Presence of clinical signs consistent with a neurologic disorder other than PD including, but not limited to, progressive supranuclear palsy, multiple system atrophy (Shy-Drager syndrome, olivopontocerebellar degeneration, striatonigral degeneration), corticobasal degeneration, Pick's disease, diffuse Lewy body disease, dementia, schizophrenia, psychosis, or hallucinations.
- Presence of clinically significant depression as measured by the HAM-D Scale with a score > 16. If the patient is on an antidepressant, the dose must be judged optimal and stable for ³ 1 month prior to randomization.
- Presence of clinically significant, in the judgment of the Investigator, urinary incontinence, cardiac arrhythmia, or symptomatic orthostatic hypotension.
- History of seizure disorder or the occurrence of 1 or more seizures within 1 year before screening.
- Any medical disability (e.g., peptic ulcer disease, severe degenerative arthritis, compromised nutritional state) or laboratory abnormality (e.g., serum creatinine > 2.0 mg/dL) that may interfere with the protocol-specified safety and efficacy measurements, present an unacceptable risk to the patient's well-being, or compromise the patient's ability to provide informed consent.
- Recent history, within the 2 years before screening, of drug or alcohol abuse.
- History of anaphylaxis.
- Previous treatment with L-Dopa for > 90 days or treatment with L-Dopa within 30 days prior to the baseline assessment.
- Treatment within the 3 months before the Baseline SPECT Scan with modafinil.
- Treatment within the 6 months before screening with neuroleptics, methylphenidate, metoclopramide, cinnarizine, flunarizine, reserpine, alpha methyldopa, amphetamine, or monoamine oxidase-A (MOA-A) inhibitors.
- Previous exposure to GPI 1485 (previously AMG-474-00).
- Treatment with an investigational agent within the 30 days before screening or scheduled to receive an investigational agent other than that specified by this protocol during the course of this study.
- Females that are pregnant, breast feeding, or do not agree to use an acceptable form of contraception.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209508
Study Director: | Antonella Favit-Van Pelt, MD, PhD | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT00209508 History of Changes |
Other Study ID Numbers: |
0501-0201 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | November 7, 2008 |
Last Verified: | November 2008 |
Keywords provided by Eisai Inc.:
Parkinson's Disease SPECT Scanning |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |