Loading clinical trials...

A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease

A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease

NCT01603069•AstraZeneca

View on ClinicalTrials.gov

Summary

This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a blinded and randomized assignment. The main objective is to see if safety and tolerability of the drug is acceptable.

Detailed Description

A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients with Parkinson's Disease

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Each patient must be able and willing to provide signed and dated informed consent prior to the study.
•Female and male patients aged 30 to 80 years at the day of enrollment (Visit 1).
•Patients must meet the criteria for "Diagnosis of idiopathic Parkinson's disease" according to the UKPDS Brain Bank criteria (Hughes et al 1992).
•Have a modified Hoehn and Yahr stage 1-2.5.
•Having no treatment for Parkinson's disease and have no need to add anti-Parkinson's disease treatment during the 14 weeks of study OR are on stable anti-Parkinson's disease medication.

Exclusion Criteria

•Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases.
•Have undergone surgery for the treatment of Parkinson's disease (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-Parkinson's disease conditions.
•Presence of dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes, defined as scoring 2 or more on item 30 of the UPDRS.
•Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e. bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study.
•Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal (GI) disease, or other major disease as judged by the investigator.

Locations (13)

Research Site

Birmingham, Alabama, United States

Research Site

Long Beach, California, United States

Research Site

New Haven, Connecticut, United States

Research Site

Atlantis, Florida, United States

Research Site

Boca Raton, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Sunrise, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Kansas City, Kansas, United States

Research Site

Bingham Farms, Michigan, United States

Key Dates

Start Date

October 1, 2012

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

July 19, 2013

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

AZD3241 300 mg BID

DRUG

AZD3241 600 mg BID

DRUG

Placebo

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations