NCT01023282

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 2, 2011

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

December 1, 2009

Last Update Submit

November 1, 2011

Conditions

Parkinson's DiseaseTolerability

Keywords

Parkinson's diseaseLevodopaDyskinesiaACR325

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    4 weeks

Study Arms (2)

ACR325

EXPERIMENTAL
Drug: ACR325

Placebo

PLACEBO COMPARATOR
Drug: ACR325Drug: Placebo

Interventions

ACR325DRUG

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

ACR325Placebo
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Paracelsus-Elena-Klinik

Kassel, Hesse, D-34128, Germany

Location

Klinik für Neurologie, Philipps-Universität Marburg

Marburg, Hesse, D-35039, Germany

Location

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

November 2, 2011

Record last verified: 2011-06

Locations

DE(2)