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

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01603069

Run by

AstraZeneca

People needed

51

Starts

2012-10-01

Expected to finish

2013-06-01

Last updated by the study team

2013-07-19

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Research Site — Omaha, Nebraska, United States
• Research Site — Lawrenceville, New Jersey, United States
• Research Site — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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