Parkinson's DiseasePhase 2NCT00314288
Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
A Phase 2 study testing Sarizotan HCl in people with Parkinson's Disease and Dyskinesia, run by EMD Serono at 51 sites in 11 countries.
Trial summary
The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease, Dyskinesia
- What is being tested?
- Sarizotan HCl
- How many people
- 360 participants
- Where
- 51 sitesin 11 countries
- Study dates
- Jul 2002to Jul 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- The subject is an out-patient
- Age 30 years or above
- Dyskinesias present during more than 25% of the waking day
- Dyskinesias at least moderately disabling
- Written informed consent
Who cannot join
- Pregnancy and/or lactation
- Participation in another study within the last 30 days
- Dementia or other psychiatric illness that prevents provision of informed consent
- History of allergic disorders such as asthma
- Known hypersensitivity to the study treatment(s)
- Known hypersensitivity to ACTH
Trial locations and contacts
51 sites in 11 countries.
51 sites in 11 countries
United States17 sites
Study site
Atlanta, Georgia
Study site
Augusta, Maine
Study site
Boston, Massachusetts
Study site
Brooklyn, New York
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Fountain Valley, California
Study site
Houston, Texas
Study site
Kansas City, Missouri
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
New York, New York
Study site
Pawtucket, Rhode Island
Study site
Philadelphia, Pennsylvania
Study site
Sunnyvale, California
Study site
Tampa, Florida
Germany7 sites
Study site
Bochum
Study site
Dresden
Study site
Leipzig
Study site
Lübeck
Study site
München
Study site
Ulm
Study site
Wiesbaden
France5 sites
Study site
Clermont-Ferrand
Study site
Marseille
Study site
Nantes
Study site
Paris
Study site
Toulouse
South Africa5 sites
Study site
George
Study site
Plumstead Cape Town
Study site
Rosebank
Study site
Sunninghill
Study site
Wilgers
United Kingdom4 sites
Study site
Cambridge
Study site
Newcastle
Study site
Nottingham
Study site
Sheffield
About this study
Official title: A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).
- Conditions
- Parkinson's Disease, Dyskinesia
- Being tested
- Sarizotan HCl
- Keywords
- Parkinson's Disease, Dyskinesia, L-dopa-induced dyskinesia
- 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.
Sarizotan HClDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startJul 2002
- Study completionJul 2003
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
- 360 participants
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314288
- Sponsor's protocol ID
- EMR 62225-006
- Status last verified
- Jan 2017
- First submitted
- 12 Apr 2006
- Last updated
- 23 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
- ClinicalTrials.gov ID
- NCT00314288
- Acronym / sponsor ID
- EMR 62225-006
- Conditions
- Parkinson's Disease, Dyskinesia
- Keywords
- Parkinson's Disease, Dyskinesia, L-dopa-induced dyskinesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Jul 2003
- First posted
- 13 Apr 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 primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female
- The subject is an out-patient
- Age 30 years or above
- Dyskinesias present during more than 25% of the waking day
- Dyskinesias at least moderately disabling
Key exclusion criteria (6 listed)
- Pregnancy and/or lactation
- Participation in another study within the last 30 days
- Dementia or other psychiatric illness that prevents provision of informed consent
- History of allergic disorders such as asthma
- Known hypersensitivity to the study treatment(s)
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 |
|---|---|---|
| Sarizotan HCl | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sarizotan HCl in people with Parkinson's Disease and Dyskinesia, run by EMD Serono at 51 sites in 11 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 6 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Germany, France, South Africa, United Kingdom and 6 more countries. 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 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.
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 23 Jan 2017.