Parkinson's DiseasePhase 3NCT00105521

Sarizotan in Participants 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 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants. 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: 398 participants
Where: 32 sitesUnited States
Study dates: 30 Sep 2004to 31 Mar 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 participant is an out-patient
The participant presents with a diagnosis of idiopathic Parkinson's disease
Prior therapy with all registered Parkinsonian medication is allowed

Who cannot join

(For female participants) The participant is pregnant or lactating
The participant is participating in another clinical study or has done so within the past 30 days
The participant has received neurosurgical intervention related to Parkinson's disease
The participant has relevant renal impairment
The participant has relevant hepatic impairment
The participant is suffering from any dementia or psychiatric illness
The participant has a history of allergic asthma

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

Study site
Albany, New York, 12205
Study site
Allentown, Pennsylvania, 18103
Study site
Baltimore, Maryland, 21207
Study site
Boston, Massachusetts, 02118-2526
Study site
Boston, Massachusetts, 02215
Study site
Charlottesville, Virginia, 22903
Study site
Chicago, Illinois, 60611-3078
Study site
Chicago, Illinois, 60612
Study site
Columbia, Maryland, 21044
Study site
Dallas, Texas, 75231
Study site
Fayetteville, Arkansas, 372703
Study site
Fort Lauderdale, Florida, 33334
Study site
Fountain Valley, California, 92708
Study site
Golden Valley, Minnesota, 55427
Study site
Hoffman Estates, Illinois, 60194
Study site
Hollywood, Florida, 33021
Study site
Lexington, Kentucky, 40503
Study site
Los Angeles, California, 90033
Study site
New York, New York, 10003
Study site
Ocala, Florida, 34471
Study site
Omaha, Nebraska, 68131
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85004
Study site
Phoenix, Arizona, 85013
Study site
Phoenix, Arizona, 85032
Study site
Port Charlotte, Florida, 33952
Study site
Scottsdale, Arizona, 85259
Study site
St. Petersburg, Florida, 33703
Study site
Syracuse, New York, 13210
Study site
Tampa, Florida, 33612
Study site
Toledo, Ohio, 43614-5811
Study site
Upland, Pennsylvania, 19013

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia

The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.

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
Sarizotan will be administered twice daily.
PlaceboDrug
Placebo matching to sarizotan will be administered twice daily.

Study groups in NCT00105521
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12. Receives: Drug: Placebo
Sarizotan 2 milligrams per day (mg/day)	Experimental	Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12. Receives: Drug: Sarizotan
Sarizotan 4 mg/day	Experimental	Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12. Receives: Drug: Sarizotan
Sarizotan 10 mg/day	Experimental	Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. Receives: Drug: Sarizotan

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.
Measured: Baseline, Week 12

Secondary outcomes (3)

Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12
Modified AIMS was a 7-item investigator-assessed scale to assess severity of dyskinesia. Each item was rated on a 0 (none) to 4 (severe) scale. Modified AIMS score was sum of the all item scores and ranged from 0 to 28, where higher score indicated increased severity. Modified AIMS score in resting state as well as with activity is reported.
Measured: Baseline, Week 12
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12
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: Baseline, Week 12
Change From Baseline in UPDRS Part III Total Score at Week 12
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. UPDRS Part III total score was the sum of the 27 answers (rated on 0 to 4-point scale) related to motor examination, and ranged from 0-108. Higher scores indicated worse motor function. Change from baseline in UPDRS Part III total score, assessed during on-time (time when the participant has no parkinsonian symptoms) as well as off-time (time when the patient experiences increased parkinsonian symptoms), is reported.
Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 200431 Mar 2006

First posted16 Mar 2005 (estimated)
Study start30 Sep 2004
Primary completion31 Mar 2006
Study completion31 Mar 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 (2)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00105521
Sponsor's protocol ID: EMR 62225-019
Status last verified: Sep 2017
First submitted: 15 Mar 2005
Last updated: 2 Apr 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Goetz CG, Damier P, Hicking C, Laska E, Muller T, Olanow CW, Rascol O, Russ H. Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Mov Disord. 2007 Jan 15;22(2):179-86. doi: 10.1002/mds.21226.
PubMed 17094088
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 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 in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia
ClinicalTrials.gov ID: NCT00105521
Acronym / sponsor ID: EMR 62225-019
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: 398 participants (actual)
Lead sponsor: EMD SeronoIndustry (pharma, biotech, devices)
Study start: 30 Sep 2004 (actual)
Primary completion: 31 Mar 2006 (actual)
Study completion: 31 Mar 2006 (actual)
First posted: 16 Mar 2005 (estimated)
Results: Posted 2 Apr 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 test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
Sarizotan 2 milligrams per day (mg/day)	Experimental	Drug: SarizotanParticipants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
Sarizotan 4 mg/day	Experimental	Drug: SarizotanParticipants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
Sarizotan 10 mg/day	Experimental	Drug: SarizotanParticipants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.

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 participant is an out-patient
The participant 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 participants) The participant is pregnant or lactating
The participant is participating in another clinical study or has done so within the past 30 days
The participant has received neurosurgical intervention related to Parkinson's disease
The participant has relevant renal impairment
The participant 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
SarizotanSarizotan will be administered twice daily.	Drug	Sarizotan 10 mg/day, Sarizotan 2 milligrams per day (mg/day), Sarizotan 4 mg/day
PlaceboPlacebo matching to sarizotan will be administered twice daily.	Drug	Placebo

Primary outcome

Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
Time frame: Baseline, Week 12
On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.

3 secondary outcomes

Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in UPDRS Part III Total Score at Week 12
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 2 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	98	83
Sarizotan 2 mg/Day	101	90
Sarizotan 4 mg/Day	97	80
Sarizotan 10 mg/Day	102	85

Primary outcome: Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: hours/day

Measure	Placebo n = 95	Sarizotan 2 mg/Day n = 96	Sarizotan 4 mg/Day n = 93	Sarizotan 10 mg/Day n = 97
Value	1.6 (3.3)	1.9 (3.8)	1.7 (3.0)	1.8 (3.1)

Population analysed: Modified intent-to-treat (ITT) population included all randomized participants who received at least one treatment dose and who had at least one follow-up visit assessment for an efficacy target outcome.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 98 (5.1%)	81 of 98 (82.7%)	Not reported
Sarizotan 2 mg/Day	8 of 101 (7.9%)	78 of 101 (77.2%)	Not reported
Sarizotan 4 mg/Day	7 of 97 (7.2%)	75 of 97 (77.3%)	Not reported
Sarizotan 10 mg/Day	2 of 102 (2%)	85 of 102 (83.3%)	Not reported

Limitations and caveats (from the sponsor): For SAEs, due diligence was done and all potential information sources have been exhausted, no further information could be retrieved apart from what is currently reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17094088Goetz CG, Damier P, Hicking C, Laska E, Muller T, Olanow CW, Rascol O, Russ H. Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Mov Disord. 2007 Jan 15;22(2):179-86. doi: 10.1002/mds.21226.
Background: 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.

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., an affiliate of Merck KGaA, Darmstadt, Germany

32 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 32 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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 2 Apr 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?

Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12 (time frame: Baseline, Week 12). 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 NCT00105521, which also lists 2 linked publications.

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 2 Apr 2018.