CLINICAL TRIALS PROFILE FOR SARIZOTAN

Clinical Trials for Sarizotan

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00105508 ↗	Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia	Completed	EMD Serono	Phase 3	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).
NCT00105521 ↗	Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia	Completed	EMD Serono	Phase 3	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.
NCT00310661 ↗	Sarizotan in the Treatment of Neuroleptic-induced Tardive Dyskinesia	Terminated	Merck KGaA	N/A	TD is a troublesome and potentially irreversible side effect associated with the use of neuroleptics. While the newer neuroleptics are improved in this regard, they all still carry the risk of TD. The present study proposes that sarizotan is a potential agent for treating neuroleptic-induced TD based on preliminary data indicating efficacy in the management of dyskinesias associated with Parkinson's disease. Its efficacy is further substantiated by pre-clinical data obtained from the vacuous chewing movement (VCM) model in rats, a model we employ ourselves in investigating the relationship between D2 occupancy and TD. The present study also examines the effects of sarizotan on cognitive function, given the association between TD and cognitive deficits.
NCT00310661 ↗	Sarizotan in the Treatment of Neuroleptic-induced Tardive Dyskinesia	Terminated	Merck KGaA, Darmstadt, Germany	N/A	TD is a troublesome and potentially irreversible side effect associated with the use of neuroleptics. While the newer neuroleptics are improved in this regard, they all still carry the risk of TD. The present study proposes that sarizotan is a potential agent for treating neuroleptic-induced TD based on preliminary data indicating efficacy in the management of dyskinesias associated with Parkinson's disease. Its efficacy is further substantiated by pre-clinical data obtained from the vacuous chewing movement (VCM) model in rats, a model we employ ourselves in investigating the relationship between D2 occupancy and TD. The present study also examines the effects of sarizotan on cognitive function, given the association between TD and cognitive deficits.
NCT00310661 ↗	Sarizotan in the Treatment of Neuroleptic-induced Tardive Dyskinesia	Terminated	Centre for Addiction and Mental Health	N/A	TD is a troublesome and potentially irreversible side effect associated with the use of neuroleptics. While the newer neuroleptics are improved in this regard, they all still carry the risk of TD. The present study proposes that sarizotan is a potential agent for treating neuroleptic-induced TD based on preliminary data indicating efficacy in the management of dyskinesias associated with Parkinson's disease. Its efficacy is further substantiated by pre-clinical data obtained from the vacuous chewing movement (VCM) model in rats, a model we employ ourselves in investigating the relationship between D2 occupancy and TD. The present study also examines the effects of sarizotan on cognitive function, given the association between TD and cognitive deficits.
NCT00314288 ↗	Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia	Completed	EMD Serono	Phase 2	The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).
NCT02790034 ↗	Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms	Terminated	Newron	Phase 2/Phase 3	This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing respiratory abnormalities in Rett Syndrome.

Clinical Trial Conditions for Sarizotan

Condition Name

Condition Name for
Intervention	Trials
Dyskinesia	3
Parkinson's Disease	3
Rett Syndrome	1
Neuroleptic-induced Tardive Dyskinesia	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Dyskinesias	4
Parkinson Disease	3
Syndrome	1
Signs and Symptoms, Respiratory	1

Clinical Trial Locations for Sarizotan

Trials by Country

Trials by Country for
Location	Trials
United States	54
India	6
Italy	2
Canada	2
United Kingdom	2

Trials by US State

Trials by US State for
Location	Trials
California	4
Illinois	4
Texas	3
Pennsylvania	3
New York	3

Clinical Trial Progress for Sarizotan

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	3
Terminated	2

Clinical Trial Sponsors for Sarizotan

Sponsor Name

Sponsor Name for
Sponsor	Trials
EMD Serono	3
Merck KGaA	1
Merck KGaA, Darmstadt, Germany	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	7
Other	1