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Completed

NCT Number: NCT00105508

Sarizotan HC1 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).

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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

Birmingham, Alabama, 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 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.

Treatment and study plan

Sarizotan

Drug

Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.

Placebo

Drug

Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

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 HCl 1 mg b.i.d. 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
Jul 26, 2018

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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