Trial · NCT00105508

Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

NCT00105508, Phase 3, Completed, EMD Serono; results first posted 2018-07-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia. Trials, record NCT00105508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00105508

On this page

Trial

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

Title: Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
NCT number: NCT00105508
Status: Completed
Phases: Phase 3
Enrollment: 506 participants, actual
Lead sponsor: EMD Serono
Conditions: Parkinson's Disease, Dyskinesia
Interventions: Sarizotan, Placebo
First posted: 2005-03-16
Last updated: 2018-07-26
Results first posted: 2018-07-26

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12	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.
Primary	Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24	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.
Primary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12	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.
Primary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24	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.

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	Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12	Week 12	Intent to treat population included all subjects who were randomized in the study.	percentage of subjects	NUMBER
PRIMARY	Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24	Week 24	Intent to treat population included all subjects who were randomized in the study.	percentage of subjects	NUMBER
PRIMARY	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12	Baseline, Week 12	Intent to treat population included all subjects who were randomized in the study. Here Overall Number of Participants Analyzed signifies those subjects who were evaluated for this outcome measure.	units on a scale	MEAN
PRIMARY	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24	Baseline, Week 24	Intent to treat population included all subjects who were randomized in the study. Here Overall Number of Participants Analyzed signifies those subjects who were evaluated for this outcome measure.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12	Sarizotan	30.4		percentage of subjects
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12	Placebo	33.2		percentage of subjects
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24	Sarizotan	37.2		percentage of subjects
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24	Placebo	39.5		percentage of subjects
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12	Sarizotan	0.1	Standard Deviation 7.45	units on a scale
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12	Placebo	-0.2	Standard Deviation 0.0	units on a scale
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24	Sarizotan	-0.2	Standard Deviation 7.92	units on a scale
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24	Placebo	-0.0	Standard Deviation 6.61	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sarizotan	253
Overall Study	STARTED	Placebo	253
Overall Study	COMPLETED	Sarizotan	213
Overall Study	COMPLETED	Placebo	217
Overall Study	NOT COMPLETED	Sarizotan	40
Overall Study	NOT COMPLETED	Placebo	36

Source ClinicalTrials.gov

Adverse events132

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	Dyskinesia	Nervous system disorders	Sarizotan	24	252
other	Dyskinesia	Nervous system disorders	Placebo	19	252
other	Parkinsonism	Nervous system disorders	Sarizotan	24	252
other	Parkinsonism	Nervous system disorders	Placebo	24	252
other	Fall	Injury, poisoning and procedural complications	Sarizotan	28	252
other	Fall	Injury, poisoning and procedural complications	Placebo	21	252
other	Depression	Psychiatric disorders	Sarizotan	15	252
other	Depression	Psychiatric disorders	Placebo	7	252
other	Nausea	Gastrointestinal disorders	Sarizotan	9	252
other	Nausea	Gastrointestinal disorders	Placebo	15	252

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sarizotan
Total, all-cause mortality	Placebo
Total, other adverse events	Sarizotan	100	252
Total, other adverse events	Placebo	86	252
Total, serious adverse events	Sarizotan	23	252
Total, serious adverse events	Placebo	25	252

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
18175337	RESULT

Source 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 comparisons1

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

Comparison
Sarizotan vs Placebo: serious adverse events

Source Trial comparisons

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.

GET https://conductscience.org/api/trials/v1/NCT00105508

GET https://conductscience.org/api/trials/v1/NCT00105508/events?page=2

API reference For AI assistants