Trial · NCT00105521

Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia

NCT00105521, Phase 3, Completed, EMD Serono; results first posted 2018-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia. Trials, record NCT00105521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00105521

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
NCT number: NCT00105521
Status: Completed
Phases: Phase 3
Enrollment: 398 participants, actual
Lead sponsor: EMD Serono
Conditions: Parkinson's Disease, Dyskinesia
Interventions: Sarizotan, Placebo
First posted: 2005-03-16
Last updated: 2018-04-02
Results first posted: 2018-04-02
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	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.
Secondary	Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Baseline, 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.
Secondary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12	Baseline, 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.
Secondary	Change From Baseline in UPDRS Part III Total Score at Week 12	Baseline, 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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	Baseline, Week 12	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.	hours/day	MEAN
SECONDARY	Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Baseline, Week 12	Modified ITT population.	units on a scale	MEAN
SECONDARY	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12	Baseline, Week 12	Modified ITT population.	units on a scale	MEAN
SECONDARY	Change From Baseline in UPDRS Part III Total Score at Week 12	Baseline, Week 12	modified ITT population.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	Placebo		1.6	Standard Deviation 3.3	hours/day
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	Sarizotan 2 mg/Day		1.9	Standard Deviation 3.8	hours/day
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	Sarizotan 4 mg/Day		1.7	Standard Deviation 3.0	hours/day
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	Sarizotan 10 mg/Day		1.8	Standard Deviation 3.1	hours/day
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Placebo	Change at Week 12: Modified AIMS at Rest	-2.7	Standard Deviation 5.7	units on a scale
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Sarizotan 2 mg/Day	Change at Week 12: Modified AIMS at Rest	-3.0	Standard Deviation 5.3	units on a scale
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Sarizotan 4 mg/Day	Change at Week 12: Modified AIMS at Rest	-2.7	Standard Deviation 4.1	units on a scale
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Sarizotan 10 mg/Day	Change at Week 12: Modified AIMS at Rest	-3.7	Standard Deviation 5.5	units on a scale
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Placebo	Change at Week 12: Modified AIMS with Activity	-3.0	Standard Deviation 5.9	units on a scale
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Sarizotan 2 mg/Day	Change at Week 12: Modified AIMS with Activity	-3.3	Standard Deviation 5.6	units on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	98
Overall Study	STARTED	Sarizotan 2 mg/Day	101
Overall Study	STARTED	Sarizotan 4 mg/Day	97
Overall Study	STARTED	Sarizotan 10 mg/Day	102
Overall Study	COMPLETED	Placebo	83
Overall Study	COMPLETED	Sarizotan 2 mg/Day	90
Overall Study	COMPLETED	Sarizotan 4 mg/Day	80
Overall Study	COMPLETED	Sarizotan 10 mg/Day	85
Overall Study	NOT COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Sarizotan 2 mg/Day	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Parkinsonism aggravated	Nervous system disorders	Placebo	27	98
other	Parkinsonism aggravated	Nervous system disorders	Sarizotan 2 mg/Day	23	101
other	Parkinsonism aggravated	Nervous system disorders	Sarizotan 4 mg/Day	35	97
other	Parkinsonism aggravated	Nervous system disorders	Sarizotan 10 mg/Day	32	102
other	Dyskinesia aggravated	Musculoskeletal and connective tissue disorders	Placebo	7	98
other	Dyskinesia aggravated	Musculoskeletal and connective tissue disorders	Sarizotan 2 mg/Day	11	101
other	Dyskinesia aggravated	Musculoskeletal and connective tissue disorders	Sarizotan 4 mg/Day	7	97
other	Dyskinesia aggravated	Musculoskeletal and connective tissue disorders	Sarizotan 10 mg/Day	10	102
other	Nausea	Gastrointestinal disorders	Placebo	6	98
other	Nausea	Gastrointestinal disorders	Sarizotan 2 mg/Day	6	101

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Sarizotan 2 mg/Day
Total, all-cause mortality	Sarizotan 4 mg/Day
Total, all-cause mortality	Sarizotan 10 mg/Day
Total, other adverse events	Placebo	81	98
Total, other adverse events	Sarizotan 2 mg/Day	78	101
Total, other adverse events	Sarizotan 4 mg/Day	75	97
Total, other adverse events	Sarizotan 10 mg/Day	85	102
Total, serious adverse events	Placebo	5	98
Total, serious adverse events	Sarizotan 2 mg/Day	8	101

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17094088	BACKGROUND	PubMed
18175337	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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