Parkinson's DiseasePhase 2NCT00451633
The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
A Phase 2 study testing E2007 in people with Parkinson's Disease, run by Eisai Inc. at 5 sites in 2 countries.
Trial summary
A randomized, double blind, placebo-controlled study employing a mixed parallel group and fixed sequence cross-over design. Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1 ratio and receive investigational drug treatment concomitant with their standard individualized… 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?
- E2007
- How many people
- 0 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Mar 2007to not given
- 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
- Patients will be eligible for the study if they meet all of the following inclusion criteria. Eligibility will be checked at screening and re-confirmed before the start of investigational drug dosing on Day -1 (ie, after completion and review of pre-dosing patient diaries and baseline assessments).
- Men or women aged between 30 and 80 years, inclusive.
- A diagnosis of idiopathic Parkinson's disease. Patients should fulfill the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (Queen Square criteria) and have a rating of 2.4 on the Hoehn \&Yahr scale when in an "off" state.
- Receiving a regimen of anti-Parkinsonian treatments that has been optimized (according to the Investigator's opinion) and has been stable for at least four weeks before baseline. The regimen is not considered to be stable if 'as required' or 'on demand' dosing is routinely used or there is regular use of apomorphine or liquid forms of levodopa.
- Taking levodopa at least three times during the waking day (not including bedtime or nighttime doses) and with a demonstrable response to each levodopa dose.
- Consistently experiencing clinically-relevant, peak-effect levodopa-induced dyskinesias during the 'on' period following the morning dose of levodopa. Patients should:
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- score .2 on Questions 32 and 33 of the full UPDRS at screening.
- have at least 3 h of 'on' time with dyskinesias on average per day recorded in the patient diary at baseline, of which 1 h is within the 4 h following the first morning dose of levodopa.
- Consistently experiencing end-of-dose motor fluctuations. Patients should:
- score .1 on Question 39 of the full UPDRS at screening.
- have at least 1.5 h of 'off' time on average per day recorded in the patient diary at baseline.
- Capable of adhering to the protocol requirements and providing written informed consent.
Who cannot join
- Patients who meet any of the following exclusion criteria will not eligible for the study.
- Eligibility will be checked at the Screening visit and re-confirmed before the start of investigational drug dosing on Day -1 (i.e., after completion and review of pre-dosing patient diaries and baseline assessments). All exclusion criteria must be observed.
- A history of drug or alcohol abuse.
- A history of suicide attempt or suicidal ideation within the past year.
- Receiving antipsychotic treatment or a history of psychotic symptoms requiring antipsychotic treatment within the past year. Patients taking anti-depressant medications can enter the study providing the regimen is stable.
- Receiving treatment with monoamine oxidase (MAO)-B inhibitors (e.g., selegiline, rasagiline).
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- Receiving treatment with medication known to induce CYP3A4 activity.
- Receiving treatment with medications believed to have an effect on levodopa-induced dyskinesias (e.g., amantadine, dextromethorphan, clozapine, olanzapine, quetiapine).
- Receiving treatment with medications known to exacerbate dyskinesias (eg, sodium valproate, CNS stimulants).
- Failing to respond to the specified levodopa challenge, or where the levodopa challenge is not medically appropriate.
- Experiencing dyskinesias unrelated to peak levodopa effect (e.g., "D-I-D" pattern).
- Previous stereotactic surgery (e.g., pallidotomy, subthalamic nucleus deep brain stimulation) for Parkinson's disease.
- Having received an investigational product within the four weeks leading up to Screening or having participated in a previous study with E2007.
- Clinically significant cognitive impairment (mini-mental state examination [MMSE] <26 or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
- Active hepatic disease, significantly reduced hepatic function or significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range).
- Clinically significant ECG abnormalities, including prolonged QT interval (defined as QTc .450 msec).
- Narrow-angle glaucoma.
- Conditions affecting the peripheral or central sensory system that could interfere with pharmacodynamic evaluations of the effects of levodopa.
- Women who are pregnant or lactating, or who are intending to become pregnant within two months of completion of the study.
- Women of child-bearing potential who do not agree to use adequate non-hormonal contraception (e.g., intrauterine device, condoms with spermicide) throughout the study.
- A history of drug hypersensitivity, especially hypersensitivity to any component of the investigational products or medication used for levodopa challenges.
- A history of melanoma or suspicious, undiagnosed skin lesions.
- Any condition that could, in the opinion of the Investigator, place the patient at increased risk or is likely to prevent completion of the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
St. Josef Hospital
Bochum, 44791
Medizinische Hochschule Hannover
Hanover, 30625
Neurologische Universitatsklinik Marburg
Marburg, D-35039
Italy2 sites
CESI - Centro Ricerche Cliniche - Fondazione Universita degli Studi
Chieti, 66013
U.O. Riabilitazione Neuromotoria, IRCCS San Raffaele Pisana
Roma, 00163
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
A randomized, double blind, placebo-controlled study employing a mixed parallel group and fixed sequence cross-over design.
Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1 ratio and receive investigational drug treatment concomitant with their standard individualized anti-Parkinsonian therapy for a total of six weeks. Investigational drug treatment for patients in the E2007 treatment group will be started 2 mg E2007 o.d. but will be escalated to 4 mg E2007 o.d. after three weeks.
- Conditions
- Parkinson's Disease
- Being tested
- E2007
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2007Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Levodopa pharmacokinetics will be assessed after each levodopa challenge. Blood samples for measurement of levodopa plasma
concentrations will be taken before and after levodopa dosing or until a full 'off' state is reached if earlier than 5 h.
Secondary outcomes (1)
Pharmacodynamic assessments of dyskinesias and motor function; Goetz/Rush dyskinesia rating scale; modified abnormal involuntary movement scale (AIMS), and Unified Parkinson's disease rating scale motor examination sub-scale (UPDRS Part 3) scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMar 2007
Why it stopped: The study group changed from patients to a healthy volunteers. A healthy-volunteer study is being planned to replace 213.
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 Eisai Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessia Nicotra, M.D., Ph.D., Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451633
- Sponsor's protocol ID
- E2007-E044-213
- Status last verified
- Oct 2013
- First submitted
- 21 Mar 2007
- Last updated
- 31 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
- ClinicalTrials.gov ID
- NCT00451633
- Acronym / sponsor ID
- E2007-E044-213
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study group changed from patients to a healthy volunteers. A healthy-volunteer study is being planned to replace 213.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- First posted
- 23 Mar 2007 (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.
A randomized, double blind, placebo-controlled study employing a mixed parallel group and fixed sequence cross-over design.
Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1 ratio and receive investigational drug treatment concomitant with their standard individualized anti-Parkinsonian therapy for a total of six weeks. Investigational drug treatment for patients in the E2007 treatment group will be started 2 mg E2007 o.d. but will be escalated to 4 mg E2007 o.d. after three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients will be eligible for the study if they meet all of the following inclusion criteria. Eligibility will be checked at screening and re-confirmed before the start of investigational drug dosing on Day -1 (ie, after completion and review of pre-dosing patient diaries and baseline assessments).
- Men or women aged between 30 and 80 years, inclusive.
- A diagnosis of idiopathic Parkinson's disease. Patients should fulfill the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (Queen Square criteria) and have a rating of 2.4 on the Hoehn \&Yahr scale when in an "off" state.
- Receiving a regimen of anti-Parkinsonian treatments that has been optimized (according to the Investigator's opinion) and has been stable for at least four weeks before baseline. The regimen is not considered to be stable if 'as required' or 'on demand' dosing is routinely used or there is regular use of apomorphine or liquid forms of levodopa.
- Taking levodopa at least three times during the waking day (not including bedtime or nighttime doses) and with a demonstrable response to each levodopa dose.
Key exclusion criteria (23 listed)
- Patients who meet any of the following exclusion criteria will not eligible for the study.
- Eligibility will be checked at the Screening visit and re-confirmed before the start of investigational drug dosing on Day -1 (i.e., after completion and review of pre-dosing patient diaries and baseline assessments). All exclusion criteria must be observed.
- A history of drug or alcohol abuse.
- A history of suicide attempt or suicidal ideation within the past year.
- Receiving antipsychotic treatment or a history of psychotic symptoms requiring antipsychotic treatment within the past year. Patients taking anti-depressant medications can enter the study providing the regimen is stable.
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 |
|---|---|---|
| E2007 | Drug | – |
Primary outcome
Levodopa pharmacokinetics will be assessed after each levodopa challenge. Blood samples for measurement of levodopa plasma
concentrations will be taken before and after levodopa dosing or until a full 'off' state is reached if earlier than 5 h.
1 secondary outcome
Pharmacodynamic assessments of dyskinesias and motor function; Goetz/Rush dyskinesia rating scale; modified abnormal involuntary movement scale (AIMS), and Unified Parkinson's disease rating scale motor examination sub-scale (UPDRS Part 3) scores.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
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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.
Alessia Nicotra, M.D., Ph.D. study director
Eisai Limited
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E2007 in people with Parkinson's Disease, run by Eisai Inc. at 5 sites in 2 countries.
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 12 inclusion and 23 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: withdrawn, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Levodopa pharmacokinetics will be assessed after each levodopa challenge. Blood samples for measurement of levodopa plasma. 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 31 Oct 2013.