Parkinson's DiseasePhase 4LeLeDysNCT00307450
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease
A Phase 4 study testing Levetiracetam in people with Parkinson's Disease, run by Technische Universität Dresden at 2 sites in Germany.
Trial summary
The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Levetiracetam
- How many people
- 34 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2006to Jul 2009
- Phase
- Phase 4
- 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
- Advanced Parkinson's disease (Hoehn \& Yahr II-IV)
- Age of 30 to 80 years
- Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
- Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
- Written informed consent
Who cannot join
- Atypical parkinsonian syndromes
- Treatment with antipsychotics
- Epilepsia or seizure in the history
- Deep brain stimulation other than DBS in STN
- Pregnant or lactating women
- Severe dementia
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Neurology at the Technical University of Dresden
Dresden, 01307
Department of Neurology at the University of Leipzig
Leipzig, 04103
About this study
Official title: Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study
The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.
Read the detailed description
The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.
The design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.
The hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.
The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.
Main inclusion criteria are:
- Advanced Parkinson's disease (Hoehn \& Yahr II-IV)
- Age of 30 to 80 years
- Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
- Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
- Written informed consent
Main exclusion criteria are:
- Atypical parkinsonian syndromes
- Treatment with antipsychotics
- Epilepsia or seizure in the history
- Deep brain stimulation other than DBS in STN
- Pregnant or lactating women
- Severe dementia
Methods:
- Primary outcome measure is the modified AIMS
- Secondary outcome measures include UPDRS, safety, patient day record
Study medication:
- Levetiracetam (upt to 2000 mg / day)
- Matched Placebo
- Conditions
- Parkinson's Disease
- Being tested
- Levetiracetam
- Keywords
- Dyskinesias, Parkinson's disease, Levetiracetam, Treatment
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
up to 200 mg per day in two dosages per day.
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified AIMS
Measured: 11 weeks
UPDRS items 32 & 33
Measured: 11 weeks
Secondary outcomes (8)
UPDRS
Measured: 11 weeks
Schwab & England scale
Measured: 11 weeks
Hoehn & Yahr scale
Measured: 11 weeks
GCI
Measured: 11 weeks
Patient day record
Measured: 11 weeks
Epsworth sleep scale
Measured: 11 weeks
Levodopa challenge test
Measured: 11 weeks
Safety measures
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma GmbH
- Investigators
- Alexander Storch, M, Principal investigator, Technical University of Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307450
- Sponsor's protocol ID
- TUD-LELEDY-007
- Other IDs
- Ethic board no.: EK10012006, EUDRAC no.: 2005-005940-18
- Acronym
- LeLeDys
- Status last verified
- Jul 2009
- First submitted
- 27 Mar 2006
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study
- ClinicalTrials.gov ID
- NCT00307450
- Acronym / sponsor ID
- LeLeDys / TUD-LELEDY-007
- Conditions
- Parkinson's Disease
- Keywords
- Dyskinesias, Parkinson's disease, Levetiracetam, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- UCB Pharma GmbH
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Mar 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.
The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.
Detailed description
The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.
The design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.
The hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.
The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.
Main inclusion criteria are:
- Advanced Parkinson's disease (Hoehn \& Yahr II-IV)
- Age of 30 to 80 years
- Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
- Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
- Written informed consent
Main exclusion criteria are:
- Atypical parkinsonian syndromes
- Treatment with antipsychotics
- Epilepsia or seizure in the history
- Deep brain stimulation other than DBS in STN
- Pregnant or lactating women
- Severe dementia
Methods:
- Primary outcome measure is the modified AIMS
- Secondary outcome measures include UPDRS, safety, patient day record
Study medication:
- Levetiracetam (upt to 2000 mg / day)
- Matched Placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced Parkinson's disease (Hoehn \& Yahr II-IV)
- Age of 30 to 80 years
- Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
- Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
- Written informed consent
Key exclusion criteria (6 listed)
- Atypical parkinsonian syndromes
- Treatment with antipsychotics
- Epilepsia or seizure in the history
- Deep brain stimulation other than DBS in STN
- Pregnant or lactating women
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 |
|---|---|---|
| Levetiracetamup to 200 mg per day in two dosages per day. | Drug | – |
Primary outcome
Modified AIMS
Time frame: 11 weeks
UPDRS items 32 & 33
Time frame: 11 weeks
8 secondary outcomes
UPDRS
Time frame: 11 weeks
Schwab & England scale
Time frame: 11 weeks
Hoehn & Yahr scale
Time frame: 11 weeks
GCI
Time frame: 11 weeks
Patient day record
Time frame: 11 weeks
Epsworth sleep scale
Time frame: 11 weeks
Levodopa challenge test
Time frame: 11 weeks
Safety measures
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
- Related InfoLink provided by the sponsor.
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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.
Alexander Storch, M principal investigator
Technical University of Dresden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levetiracetam in people with Parkinson's Disease, run by Technische Universität Dresden at 2 sites in Germany.
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 5 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: finished, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified AIMS (time frame: 11 weeks). The study lists 2 primary outcomes in all. 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 3 Aug 2009.