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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105521
• Other study ID #: EMR 62225-019
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2005
• Last updated: September 4, 2017
• Start date: September 30, 2004
• Est. completion date: March 31, 2006

Study information

• Verified date: September 2017
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: March 31, 2006
• Est. primary completion date: March 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesia
• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Sarizotan
Sarizotan will be administered twice daily.
• Placebo
Placebo matching to sarizotan will be administered twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

References & Publications (2)

Goetz CG, Damier P, Hicking C, Laska E, Müller T, Olanow CW, Rascol O, Russ H. Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Mov Disord. 2007 Jan 15;22(2):179-86. — View Citation

Goetz CG, Laska E, Hicking C, Damier P, Müller T, Nutt J, Warren Olanow C, Rascol O, Russ H. Placebo influences on dyskinesia in Parkinson's disease. Mov Disord. 2008 Apr 15;23(5):700-7. doi: 10.1002/mds.21897. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Diary-Based On-Time Without Dyskinesia at 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	Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at 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
Secondary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at 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
Secondary	Change From Baseline in UPDRS Part III Total Score at 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