Parkinson's DiseasePhase 3NCT00105508
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
A Phase 3 study testing Sarizotan in people with Parkinson's Disease and Dyskinesia, run by EMD Serono at 31 sites in United States.
Trial summary
The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD). 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 31 sitesUnited States
- Study dates
- 30 Sep 2004to 28 Feb 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The subject is an out-patient.
- The subject presents with a diagnosis of idiopathic Parkinson's disease.
- Prior therapy with all registered Parkinsonian medication is allowed.
Who cannot join
- (For female subjects) The subject is pregnant or lactating.
- The subject is participating in another clinical study or has done so within the past 30 days.
- The subject has received neurosurgical intervention related to PD.
- The subject has relevant renal impairment.
- The subject has relevant hepatic impairment.
- The subject is suffering from any dementia or psychiatric illness.
- The subject has a history of allergic asthma.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Birmingham, Alabama, 35233
Study site
Boston, Massachusetts, 02215
Study site
Brentwood, Tennessee, 37027
Study site
Chicago, Illinois, 60611-3078
Study site
Danbury, Connecticut, 06810
Study site
Decatur, Georgia, 30033
Study site
Des Moines, Iowa, 50309
Study site
Durham, North Carolina, 27705
Study site
Edison, New Jersey, 08818
Study site
Englewood, Colorado, 80113
Study site
Farmington, Connecticut, 06030-1840
Study site
Huntsville, Alabama, 35801
Study site
Jacksonville, Florida, 32209
Study site
Jacksonville, Florida, 32216
Study site
La Jolla, California, 92037
Study site
Maitland, Florida, 32751
Study site
Milwaukee, Wisconsin, 53233
Study site
New Hyde Park, New York, 11040
Study site
New Hyde Park, New York, 12401
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10016
Study site
Oklahoma City, Oklahoma, 73104
Study site
Oxnard, California, 93030
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Sacramento, California, 95817
Study site
Scarborough, Maine, 04074
Study site
South Ogden, Utah, 84403
Study site
Southfield, Michigan, 48034
Study site
Spokane, Washington, 99204
Study site
Springfield, Illinois, 62702
Study site
St. Petersburg, Florida, 33703
About this study
Official title: A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
- Conditions
- Parkinson's Disease, Dyskinesia
- Being tested
- Sarizotan, Placebo
- Keywords
- Parkinson's Disease, Dyskinesia, Dyskinesia associated with dopaminergic 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.
SarizotanDrug
Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.
PlaceboDrug
Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sarizotan | Experimental | Not described Receives: Drug: Sarizotan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Measured: Week 12
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Measured: Week 24
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline.
Measured: Baseline, Week 12
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2005 (estimated)
- Study start30 Sep 2004
- Primary completion28 Feb 2006
- Study completion28 Feb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105508
- Sponsor's protocol ID
- EMR 62225-018
- Status last verified
- Jul 2018
- First submitted
- 15 Mar 2005
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Goetz CG, Laska E, Hicking C, Damier P, Muller T, Nutt J, Warren Olanow C, Rascol O, Russ H. Placebo influences on dyskinesia in Parkinson's disease. Mov Disord. 2008 Apr 15;23(5):700-7. doi: 10.1002/mds.21897.
PubMed 18175337
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
- ClinicalTrials.gov ID
- NCT00105508
- Acronym / sponsor ID
- EMR 62225-018
- Conditions
- Parkinson's Disease, Dyskinesia
- Keywords
- Parkinson's Disease, Dyskinesia, Dyskinesia associated with dopaminergic treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2004 (actual)
- Primary completion
- 28 Feb 2006 (actual)
- Study completion
- 28 Feb 2006 (actual)
- First posted
- 16 Mar 2005 (estimated)
- Results
- Posted 26 Jul 2018
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 determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarizotan | Experimental | Drug: Sarizotan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is an out-patient.
- The subject presents with a diagnosis of idiopathic Parkinson's disease.
- Prior therapy with all registered Parkinsonian medication is allowed.
Key exclusion criteria (7 listed)
- (For female subjects) The subject is pregnant or lactating.
- The subject is participating in another clinical study or has done so within the past 30 days.
- The subject has received neurosurgical intervention related to PD.
- The subject has relevant renal impairment.
- The subject has relevant hepatic impairment.
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 |
|---|---|---|
| SarizotanSubjects will receive sarizotan 1 milligram orally twice daily for 24 weeks. | Drug | Sarizotan |
| PlaceboSubjects will receive placebo matched to sarizotan orally twice daily for 24 weeks. | Drug | Placebo |
Primary outcome
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12
Time frame: Week 12
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24
Time frame: Week 24
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12
Time frame: Baseline, Week 12
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24
Time frame: Baseline, Week 24
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18175337Goetz CG, Laska E, Hicking C, Damier P, Muller T, Nutt J, Warren Olanow C, Rascol O, Russ H. Placebo influences on dyskinesia in Parkinson's disease. Mov Disord. 2008 Apr 15;23(5):700-7. doi: 10.1002/mds.21897.
- EudraCT results summary synopsisLink provided by the sponsor.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Medical Responsible study director
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sarizotan in people with Parkinson's Disease and Dyskinesia, run by EMD Serono at 31 sites in United States.
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 3 inclusion and 7 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 (time frame: Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105508, which also lists 1 linked publication.
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 26 Jul 2018.