Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients

NeuroSearch A/S

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease; Tolerability

Treatments: Drug: Placebo; Drug: ACR325

Study type: Interventional

Funder types: Industry

Identifiers

NCT01023282

ACR325C005

Details and patient eligibility

About

The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients and evaluate the effect on levodopa induced dyskinesias.

Enrollment: 22 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson"s disease according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
• Levodopa induced dyskinesia

Exclusion criteria

• Previous surgery for Parkinson's disease
• Any current or history of heart condition or increased pro-arrhythmic risk
• Severe or ongoing unstable medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

ACR325

Experimental group

Treatment:

Drug: ACR325

Placebo

Placebo Comparator group

Treatment:

Drug: ACR325

Drug: Placebo