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

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ClinicalTrials.gov Identifier: NCT00105521
Recruitment Status : Completed
First Posted : March 16, 2005
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Dyskinesia Drug: Sarizotan Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 30, 2004
Actual Primary Completion Date : March 31, 2006
Actual Study Completion Date : March 31, 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105521


  Show 32 Study Locations
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Publications:
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00105521     History of Changes
Other Study ID Numbers: EMR 62225-019
First Posted: March 16, 2005    Key Record Dates
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018
Last Verified: September 2017

Keywords provided by EMD Serono:
Parkinson's Disease
Dyskinesia
Dyskinesia associated with dopaminergic treatment

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms