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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Levetiracetam

Placebo

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

NCT ID

NCT00291733

First Posted

February 14, 2006

Last Updated

November 14, 2007

Sponsor

1st Hospital of Social Security Services

Collaborators

UCB Pharma

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: