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NCT00105508

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

Completed Phase 3 Results posted Last updated 26 July 2018
What this trial tests

Phase 3 trial testing Sarizotan in Parkinson's Disease in 506 participants. Completed in 28 February 2006.

Timeline
30 September 2004
Primary endpoint
28 February 2006
28 February 2006

Quick facts

Lead sponsorEMD Serono
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment506
Start date30 September 2004
Primary completion28 February 2006
Estimated completion28 February 2006
Sites31 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

EMD Serono — full company profile →

Who can join

30 and older, any sex, with Parkinson's Disease or Dyskinesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 Primary · 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 fro

GroupValue95% CI
Sarizotan30.4
Placebo33.2
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 Primary · 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 fro

GroupValue95% CI
Sarizotan37.2
Placebo39.5
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12 Primary · 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.

GroupValue95% CI
Sarizotan0.1± 7.45
Placebo-0.2± 0.0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24 Primary · 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.

GroupValue95% CI
Sarizotan-0.2± 7.92
Placebo-0.0± 6.61

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sarizotan
Serious: 23/252 (9%)
Deaths:
Placebo
Serious: 25/252 (10%)
Deaths:

Serious adverse events (61 terms)

ReactionSystemSarizotanPlacebo
FallInjury, poisoning and procedural complications
Urinary tract infectionInfections and infestations
Abdominal painGastrointestinal disorders
Hepatic traumaInjury, poisoning and procedural complications
Hip fractureInjury, poisoning and procedural complications
Lumbar vertebral fractureInjury, poisoning and procedural complications
Pelvic fractureInjury, poisoning and procedural complications
Upper limb fractureInjury, poisoning and procedural complications
Wrist fractureInjury, poisoning and procedural complications
DyskinesiaNervous system disorders
DystoniaNervous system disorders
HypoaesthesiaNervous system disorders
ParkinsonismNervous system disorders
SyncopeNervous system disorders
Abscess limbInfections and infestations
Arthritis bacterialInfections and infestations
CellulitisInfections and infestations
Escherichia bacteraemiaInfections and infestations
UrosepsisInfections and infestations
Wound infectionInfections and infestations
Hernia repairSurgical and medical procedures
Hip arthroplastySurgical and medical procedures
Hip surgerySurgical and medical procedures
Knee arthroplastySurgical and medical procedures
Spinal fusion surgerySurgical and medical procedures
Other adverse events (5 terms — click to expand)

ReactionSystemSarizotanPlacebo
FallInjury, poisoning and procedural complications
DyskinesiaNervous system disorders
ParkinsonismNervous system disorders
DepressionPsychiatric disorders
NauseaGastrointestinal disorders

Most-reported serious reactions: Fall, Urinary tract infection, Abdominal pain, Hepatic trauma, Hip fracture, Lumbar vertebral fracture, Pelvic fracture, Upper limb fracture.

Data from ClinicalTrials.gov NCT00105508 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
    Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
  2. Current Therapies in Clinical Trials of Parkinson's Disease: A 2021 Update.
    Prasad EM, Hung SY. · · 2021 · cited 66× · PMID 34451813 · DOI 10.3390/ph14080717

Verify or expand the search:

Other trials of Sarizotan

Trials testing the same drug.

Other recruiting trials for Parkinson's Disease

Currently open trials in the same condition.

Other EMD Serono trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00105508.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing