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

Randomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary Measure

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01023282

Enrollment

Registered

2009-12-02

Start date

2009-11-30

Completion date

2011-04-30

Last updated

2011-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease, Tolerability

Keywords

Parkinson's disease, Levodopa, Dyskinesia, ACR325

Brief summary

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

Interventions

DRUGACR325

Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks

DRUGPlacebo

Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of idiopathic Parkinsons 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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	4 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026