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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.
Study objectives :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 500mg levetiracetam for one week and 1000mg levetiracetam for one week |
|
| 2 | Placebo Comparator | placebo |
|
| 3 | Active Comparator | After crossover arm 3 equals arm 1 |
|
| 4 | Placebo Comparator | After crossover arm 4 equals arm 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of "on without dyskinesias" and "off" time from patient diaries. Changes in severity and duration of LID according to the UPDRS , Schwab & England scale and also Goetz dyskinesia scale after a levodopa challenge dose. | 24 hours |
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Inclusion Criteria:
Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.
Other inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pantelis Stathis, MD | 1st Hospital of Social Security Services | Study Chair |
| Spiros Konitsiotis, MD | Department of Neurology, University of Ioannina | Principal Investigator |
| Vasilis Kyriakakis, MD | Department of Neurology, General Hospital of Lamia | Principal Investigator |
| Georgios Tagaris, MD | Department of Neurology, PGNA "Georgios Genimatas" | Principal Investigator |
| Kostas Papadopoulos, MD | Department of Neurology, Hospital of Mental Diseases of Tripolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, 1st Hospital of Social Security Services | Athens | 151-27 | Greece |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Drug | Placebo tabl |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |