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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: AZD3241 300 mg BID; Drug: AZD3241 600 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01603069

EudraCT number: 2012-001313-16

D0490C00005

Details and patient eligibility

About

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.

Full 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

Enrollment: 51 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 3 patient groups, including a placebo group

AZD3241, 300 mg

Active Comparator group

Description:

AZD3241 300 mg BID

Treatment:

Drug: AZD3241 300 mg BID

AZD3241, 600 mg

Active Comparator group

Description:

AZD3241 600 mg BID

Treatment:

Drug: AZD3241 600 mg BID

Placebo

Placebo Comparator group

Description:

Placebo to AZD3241

Treatment:

Drug: Placebo