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Completed

NCT Number: NCT00105521

Sarizotan in Participants 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesia Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sarizotan

Drug

Sarizotan will be administered twice daily.

Placebo

Drug

Placebo matching to sarizotan will be administered twice daily.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 16, 2005
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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