Parkinson's DiseasePhase 2NCT01172379
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias
A Phase 2 study testing E2007 in people with Parkinson's Disease, run by Eisai Limited at 33 sites in 6 countries.
Trial summary
The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in Parkinson's Disease patients who have "wearing off" motor fluctuations and "on" period dyskenisias. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- E2007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 33 sitesin 6 countries
- Study dates
- May 2004to Feb 2005
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with idiopathic PD fulfilling the Queen Square Brain Bank diagnostic criteria, with good response to levodopa.
- Patients must be aged 30-75 inclusive. Patients aged between 76-80 (inclusive) may be enrolled with the prior agreement of the Study Medical Monitor.
- Patients must have motor fluctuations of the wearing "off" type with the presence of at least two and half hours of "off" time during the waking day and at least 90 minutes of "off" time during the eight hour period following the morning dose of levodopa each per day as evidenced by history at Screening and confirmed by diary data collected between Screening and Baseline.
- Patients must have clinically relevant dyskinesias during the "on" period following each morning dose of his/her current medication.
- Patients must rate between II-IV on the Hoehn and Yahr scale when in an "off" state.
- Patients must be taking levodopa at least three times daily.
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- Patients must have been on a fixed dose of any treatments for PD for at least 4 weeks prior to the Baseline Visit.
- In the Investigator's opinion patients must be able to distinguish their own motor states and the absence or presence of dyskinesias.
- Patients must be capable of giving full written informed consent.
- In the Investigator's opinion patients must be of capable of completing patient diary cards according to instructions.
- In the Investigator's opinion patients who are good candidates and able to complete the study.
Who cannot join
- Pregnant or lactating women.
- Women of child-bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, IUD or barrier method plus hormonal method). These patients must have a negative serum B-HCG test at the Initial Screening Visit and a negative urine pregnancy test at the Baseline Visit. These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential.
- Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception.
- Patients with a past or present history of drug or alcohol abuse.
- Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however, the dose must be stable for 8 weeks prior to the Baseline Visit.
- Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
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- Patients with significantly elevated liver enzymes (abnormal bilirubin or seum transaminase levels of more than 1.5 times the upper normal limit).
- Patients currently receiving treatment with medication that could significantly interfere with gastric absorption.
- Patients with current or prior treatment (within 4 weeks prior to the Baseline Visit) with medication known to induce the enzyme cytochrome P450 3A4 including but not limited to: carbamazepine; dexamethasone; ethosuximide; phenobarbital; phenytoin; primidone; rifabutin; rifampacin; and St. John's Wort.
- Current or prior treatment (within 4 weeks prior to Baseline Visit) with methyldopa, budipine, reserpine or intermittent use of liquid forms of levodopa or apomorphine.
- Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease.
- Patients receiving deep brain stimulation.
- Patients who have received an investigational product within 12 weeks prior to Baseline Visit or patients that have participated in a previous study with E2007.
- Patients with clinically significant cognitive impairment (MMSE ; 24 and/or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
- Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson's disease (mild sensory or pain syndromes limited to off periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
- Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
Germany15 sites
Humboldt Universit?t Charite Neurologische Klinik
Berlin, D-13353
Klinikum der Friedrich-Wilhelms- Univerit?t Bonn
Bonn, D-53105
Zentralkrankenhaus Reinkenheide Neurologische Klinik
Bremerhaven, D-27574
Klinikum der Heinrich-Heine- Universit?t
D?sseldorf, D-40225
Praxis
Erbach im Odenwald, D-64711
Klinikum der Georg-August- Universit?t
G?ttingen, D-37099
Universit?tskrankenh aus Hamburg Eppendorf
Hamburg, D-20246
Krankenhaus Hanau
Hanau, D-63450
Medizinische Hochschule Hannover
Hanover, D-30623
Universit?tsklinikum Heidelberg
Heidelberg, D-69120
Universit?tsklinikum
Homburg/Saar, D-66421
Paracelsus-Elena-Kli nik
Kassel, D-34126
Hopital Roger Salengro
Lille, 59037
Parkinson's Competence Network Germany Dept. of Neurology - Philipps-University Marburg
Marburg, Hesse, 35039
Universit?tsklinikum Rostock Klinik f?r Neurologie
Rostock, D-18147
Czechia5 sites
Clinic of Neurology, Faculty Hospital Olomouc
Olomouc, 775 20
Private Neurology Practise
Ostrava, 702 00
Department of Neurology, Regional Hospital Pardubice
Pardubice, 532 03
First Faculty of Medicine Charles University
Prague, 120 00
Dept. of Neurology - Second Faculty of Medicine Charles University
Prague, 84 - 150 06
Italy5 sites
Reparto di Neurologia - Ospedale Misericordia
Grosseto, 171 - 58100
Universit? di Napoli Federico II
Naples, 5 - 80131
Unit? Operativa Parkinson e Disordini del Movimento
Pavia, 6 - 27100
Istituto Neuromed SRL Neurologia
Pozzilli, 18 - 86077
III Clinica Neurologica
Roma, 30 - 00185
Spain4 sites
Hospital Vall d'Hebron
Barcelona, 119 - 08035
Hospital del Mar
Barcelona, 25-29 08003
Hospital Clinic I Provincial de Barcelona
Barcelona, 8036
Hospital Mutua de Terrassa
Terrassa, 25-27 - 08221
Serbia3 sites
Militzary Medical Academy
Belgrade, 11000
Clinic of Neurology
Belgrade
Institute of Neurology
Belrade
France1 site
Centre D'Investigation Clinique Pavillon Riser - Hopital Purpan
Toulouse, 31059
About this study
The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in Parkinson's Disease patients who have "wearing off" motor fluctuations and "on" period dyskenisias.
Read the detailed description
This is a randomised, double-blind, placebo-controlled, dose-ranging multicentre study with parallel groups. Patients will be equally randomized to receive 0.5 mg, 1 mg or 2 mg of E2007 or matching placebo for 12 weeks (84 days) in addition to their stable antiparkinsonian treatment. The study will involve two overnight in-patient stays. The first of these will be for 2 nights and 3 days and the second will be for 1 night and 2 days. The remainder of the study will be conducted on an outpatient basis.
- Conditions
- Parkinson's Disease
- Being tested
- E2007, Placebo Comparator
- 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
Experimental 1 Drug: E2007
0.5 mg 1 tablet per day
E2007Drug
Experimental 2 Drug: E2007
1.0 mg 1 tablet per day
E2007Drug
Drug: E2007
2.0 mg 1 tablet per day
Placebo ComparatorOther
Placebo 1 tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Not described Receives: Drug: E2007 |
| Experimental 2 | Experimental | Not described Receives: Drug: E2007 |
| Experimental 3 | Experimental | Not described Receives: Drug: E2007 |
| Placebo Comparator | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startMay 2004
- Primary completionFeb 2005
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.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2 participants
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathan Webster, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172379
- Sponsor's protocol ID
- E2007-E044-204
- Status last verified
- Aug 2014
- First submitted
- 26 Jul 2010
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias
- ClinicalTrials.gov ID
- NCT01172379
- Acronym / sponsor ID
- E2007-E044-204
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Feb 2005 (actual)
- First posted
- 29 Jul 2010 (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 purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in Parkinson's Disease patients who have "wearing off" motor fluctuations and "on" period dyskenisias.
Detailed description
This is a randomised, double-blind, placebo-controlled, dose-ranging multicentre study with parallel groups. Patients will be equally randomized to receive 0.5 mg, 1 mg or 2 mg of E2007 or matching placebo for 12 weeks (84 days) in addition to their stable antiparkinsonian treatment. The study will involve two overnight in-patient stays. The first of these will be for 2 nights and 3 days and the second will be for 1 night and 2 days. The remainder of the study will be conducted on an outpatient basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: E2007 |
| Experimental 2 | Experimental | Drug: E2007 |
| Experimental 3 | Experimental | Drug: E2007 |
| Placebo Comparator | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients with idiopathic PD fulfilling the Queen Square Brain Bank diagnostic criteria, with good response to levodopa.
- Patients must be aged 30-75 inclusive. Patients aged between 76-80 (inclusive) may be enrolled with the prior agreement of the Study Medical Monitor.
- Patients must have motor fluctuations of the wearing "off" type with the presence of at least two and half hours of "off" time during the waking day and at least 90 minutes of "off" time during the eight hour period following the morning dose of levodopa each per day as evidenced by history at Screening and confirmed by diary data collected between Screening and Baseline.
- Patients must have clinically relevant dyskinesias during the "on" period following each morning dose of his/her current medication.
- Patients must rate between II-IV on the Hoehn and Yahr scale when in an "off" state.
Key exclusion criteria (16 listed)
- Pregnant or lactating women.
- Women of child-bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, IUD or barrier method plus hormonal method). These patients must have a negative serum B-HCG test at the Initial Screening Visit and a negative urine pregnancy test at the Baseline Visit. These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential.
- Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception.
- Patients with a past or present history of drug or alcohol abuse.
- Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however, the dose must be stable for 8 weeks prior to the Baseline Visit.
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 |
|---|---|---|
| E2007Experimental 1 Drug: E2007 0.5 mg 1 tablet per day | Drug | Experimental 1 |
| E2007Experimental 2 Drug: E2007 1.0 mg 1 tablet per day | Drug | Experimental 2 |
| E2007Drug: E2007 2.0 mg 1 tablet per day | Drug | Experimental 3 |
| Placebo ComparatorPlacebo 1 tablet per day | Other | Placebo Comparator |
Primary outcome
Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias).
Time frame: 12 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 22 Aug 2014.
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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.
Jonathan Webster study director
Eisai Limited
33 sites in 6 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 Limited at 33 sites in 6 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 11 inclusion and 16 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 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, Czechia, Italy, Spain, Serbia and 1 more country. 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?
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?
Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias). (time frame: 12 Weeks). 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 22 Aug 2014.