Sarizotan HC1 in Patients 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 HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105508
• Other study ID #: EMR 62225-018
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2004
• Est. completion date: February 28, 2006

Study information

• Verified date: July 2018
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: February 28, 2006
• Est. primary completion date: February 28, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Sarizotan
Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.
• Placebo
Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

References & Publications (1)

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	Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at 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.	Week 12
Primary	Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at 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.	Week 24
Primary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at 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.	Baseline, Week 12
Primary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at 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.	Baseline, Week 24

External Links

•   EudraCT results summary synopsis