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Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease

Primary Purpose

Levodopa Induced Dyskinesia

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Levetiracetam
Placebo
Sponsored by
1st Hospital of Social Security Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Levodopa Induced Dyskinesia focused on measuring Levetiracetam, Levodopa-induced dyskinesias, Parkinson's

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank. Other inclusion criteria: Patients between ages 30 and 80 Hoehn and Yahr stage of PD over IIb Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV Patient is willing to adhere to protocol requirements as evidence by written informed consent Exclusion Criteria: Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk. Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal. Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia. Patient has a low Mini-mental Examination MMSE score <25 or has a history of bipolar psychosis or schizophrenia. Patient is unwilling to sign an informed consent or to comply with protocol requirements. Patient is taking or has taken in the past month amantadine.

Sites / Locations

  • Department of Neurology, 1st Hospital of Social Security Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

500mg levetiracetam for one week and 1000mg levetiracetam for one week

placebo

After crossover arm 3 equals arm 1

After crossover arm 4 equals arm 2

Outcomes

Primary Outcome Measures

Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2006
Last Updated
November 14, 2007
Sponsor
1st Hospital of Social Security Services
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00291733
Brief Title
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease
Official Title
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
1st Hospital of Social Security Services
Collaborators
UCB Pharma

4. Oversight

5. Study Description

Brief Summary
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 : To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD). To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Levodopa Induced Dyskinesia
Keywords
Levetiracetam, Levodopa-induced dyskinesias, Parkinson's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
500mg levetiracetam for one week and 1000mg levetiracetam for one week
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
3
Arm Type
Active Comparator
Arm Description
After crossover arm 3 equals arm 1
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
After crossover arm 4 equals arm 2
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tabl
Primary Outcome Measure Information:
Title
Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank. Other inclusion criteria: Patients between ages 30 and 80 Hoehn and Yahr stage of PD over IIb Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV Patient is willing to adhere to protocol requirements as evidence by written informed consent Exclusion Criteria: Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk. Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal. Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia. Patient has a low Mini-mental Examination MMSE score <25 or has a history of bipolar psychosis or schizophrenia. Patient is unwilling to sign an informed consent or to comply with protocol requirements. Patient is taking or has taken in the past month amantadine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pantelis Stathis, MD
Organizational Affiliation
1st Hospital of Social Security Services
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Spiros Konitsiotis, MD
Organizational Affiliation
Department of Neurology, University of Ioannina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vasilis Kyriakakis, MD
Organizational Affiliation
Department of Neurology, General Hospital of Lamia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgios Tagaris, MD
Organizational Affiliation
Department of Neurology, PGNA "Georgios Genimatas"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kostas Papadopoulos, MD
Organizational Affiliation
Department of Neurology, Hospital of Mental Diseases of Tripolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, 1st Hospital of Social Security Services
City
Athens
ZIP/Postal Code
151-27
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease

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