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

September 4, 2017 updated by: EMD Serono

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

398

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

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 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

Exclusion Criteria:

  • (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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
Drug: Placebo
Placebo matching to sarizotan will be administered twice daily.
Experimental: Sarizotan 2 milligrams per day (mg/day)
Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
Drug: Sarizotan
Sarizotan will be administered twice daily.
Experimental: Sarizotan 4 mg/day
Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
Drug: Sarizotan
Sarizotan will be administered twice daily.
Experimental: Sarizotan 10 mg/day
Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Drug: Sarizotan
Sarizotan will be administered twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12
Time Frame: 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.
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
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.
Baseline, Week 12
Change From Baseline in UPDRS Part III Total Score 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. 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.
Baseline, Week 12

Collaborators and Investigators

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

Sponsor

EMD Serono

Investigators

  • Study Director: Medical Responsible, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

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

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)

March 31, 2006

Study Completion (Actual)

March 31, 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)

April 2, 2018

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 62225-019

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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