Levodopa Induced DyskinesiaPhase 2NCT00291733
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease
A Phase 2 study testing Levetiracetam in people with Levodopa Induced Dyskinesia, run by 1st Hospital of Social Security Services at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Levodopa Induced Dyskinesia
- What is being tested?
- Levetiracetam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- May 2006to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Neurology, 1st Hospital of Social Security Services
Athens, 151-27
About this study
Official title: Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
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.
- Conditions
- Levodopa Induced Dyskinesia
- Being tested
- Levetiracetam, Placebo
- Keywords
- Levetiracetam, Levodopa-induced dyskinesias, Parkinson's
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
PlaceboDrug
Placebo tabl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 500mg levetiracetam for one week and 1000mg levetiracetam for one week Receives: Drug: Levetiracetam |
| 2 | Placebo comparator | placebo Receives: Drug: Placebo |
| 3 | Active comparator | After crossover arm 3 equals arm 1 Receives: Drug: Levetiracetam |
| 4 | Placebo comparator | After crossover arm 4 equals arm 2 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startMay 2006
- Study completionOct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Levodopa Induced DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1st Hospital of Social Security Services
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Pantelis Stathis, MD, Study chair, 1st Hospital of Social Security ServicesSpiros Konitsiotis, MD, Principal investigator, Department of Neurology, University of IoanninaVasilis Kyriakakis, MD, Principal investigator, Department of Neurology, General Hospital of LamiaGeorgios Tagaris, MD, Principal investigator, Department of Neurology, PGNA "Georgios Genimatas"Kostas Papadopoulos, MD, Principal investigator, Department of Neurology, Hospital of Mental Diseases of Tripolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291733
- Sponsor's protocol ID
- VALID-PD
- Status last verified
- Nov 2007
- First submitted
- 14 Feb 2006
- Last updated
- 15 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT00291733
- Acronym / sponsor ID
- VALID-PD
- Conditions
- Levodopa Induced Dyskinesia
- Keywords
- Levetiracetam, Levodopa-induced dyskinesias, Parkinson's
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- 1st Hospital of Social Security ServicesUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- May 2006
- Study completion
- Oct 2007 (estimated)
- First posted
- 15 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Levetiracetam500mg levetiracetam for one week and 1000mg levetiracetam for one week |
| 2 | Placebo comparator | Drug: Placeboplacebo |
| 3 | Active comparator | Drug: LevetiracetamAfter crossover arm 3 equals arm 1 |
| 4 | Placebo comparator | Drug: PlaceboAfter crossover arm 4 equals arm 2 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week | Drug | 1, 3 |
| PlaceboPlacebo tabl | Drug | 2, 4 |
Primary outcome
Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
Time frame: 24 hours
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pantelis Stathis, MD study chair
1st Hospital of Social Security Services
Spiros Konitsiotis, MD principal investigator
Department of Neurology, University of Ioannina
Vasilis Kyriakakis, MD principal investigator
Department of Neurology, General Hospital of Lamia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam in people with Levodopa Induced Dyskinesia, run by 1st Hospital of Social Security Services at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2007; AzTrials last refreshed its copy on 8 Nov 2026.