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

July 24, 2018 updated by: EMD Serono

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

506

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
      • Huntsville, Alabama, United States, 35801
    • California
      • La Jolla, California, United States, 92037
      • Oxnard, California, United States, 93030
      • Sacramento, California, United States, 95817
    • Colorado
      • Englewood, Colorado, United States, 80113
    • Connecticut
      • Danbury, Connecticut, United States, 06810
      • Farmington, Connecticut, United States, 06030-1840
    • Florida
      • Jacksonville, Florida, United States, 32209
      • Jacksonville, Florida, United States, 32216
      • Maitland, Florida, United States, 32751
      • Saint Petersburg, Florida, United States, 33703
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Chicago, Illinois, United States, 60611-3078
      • Springfield, Illinois, United States, 62702
    • Iowa
      • Des Moines, Iowa, United States, 50309
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Maine
      • Scarborough, Maine, United States, 04074
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Southfield, Michigan, United States, 48034
    • New Jersey
      • Edison, New Jersey, United States, 08818
    • New York
      • New Hyde Park, New York, United States, 11040
      • New Hyde Park, New York, United States, 12401
      • New York, New York, United States, 10016
    • North Carolina
      • Durham, North Carolina, United States, 27705
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
    • Utah
      • South Ogden, Utah, United States, 84403
    • Washington
      • Spokane, Washington, United States, 99204
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
Experimental: Sarizotan
Drug: Sarizotan
Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12
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.
Week 24
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.
Baseline, Week 12
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.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2004

Primary Completion (Actual)

February 28, 2006

Study Completion (Actual)

February 28, 2006

Study Registration Dates

First Submitted

March 15, 2005

First Submitted That Met QC Criteria

March 15, 2005

First Posted (Estimate)

March 16, 2005

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 62225-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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