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A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson’s Disease

Sponsor:

Brief Summary:

The purpose of this study is to test the efficacy and safety of liraglutide in the treatment
of patients with idiopathic Parkinson’s disease (PD).

Criteria

Inclusion Criteria:

– Diagnosis of idiopathic PD according to the United Kingdom Parkinson’s Disease Society
Brain Bank (UKPDSBB) criteria for at least 2 years

– Responsive to levodopa or dopaminergic treatment

– Male or female between 25 and 85 years of age at time of enrollment

– Women of child-bearing potential (WOCBP) must agree to use a reliable method of
contraception (e.g., oral contraceptive or long-term injectable or implantable
hormonal contraceptive, double barrier methods (such as condom plus diaphragm,
condom plus spermicide foam, condom plus sponge), or intra-uterine devices)
throughout the duration of the trial period and must have a negative serum
pregnancy test at screening

– Male patients with female partners who have child bearing potential must agree to
use adequate contraception throughout the duration of the trial period

– Capacity to give informed consent

– Ability to self-administer, or to arrange a care partner to administer trial drug, to
comply with trial protocol, and to attend necessary clinic visits off medication

Exclusion Criteria:

– Diagnosis or suspicion of other causes for Parkinsonism, including drug- or
toxin-induced parkinsonism and other neurodegenerative conditions, including multiple
system atrophy, progressive supranuclear palsy, Huntington’s disease, Wilson’s
disease, or Alzheimer’s disease

– Active treatment with anticholinergic medications (e.g., trihexyphenidyl, tricyclic
antidepressants)

– Known abnormality on CT or MRI brain imaging considered to cause symptoms or signs of
neurological dysfunction, or considered likely to compromise compliance with trial
protocol

– Concurrent dementia defined by a score lower than 120 on the MADRS-2 and/or inability
to complete scale per neuropsychologist discretion

– Concurrent severe depression defined by a score greater than 29 on the Beck Depression
Inventory

– Prior intracerebral surgical intervention for PD, including deep brain stimulation,
lesional surgery, growth factor administration, gene therapy, or cell transplant

– Already actively participating in a trial of a device, drug, or surgical treatment for
PD, or trial participation within 30 days prior to the baseline visit

– Diagnosis of diabetes mellitus of any type, established historically or by:

– Fasting plasma glucose levels equal or above 126 mg/dl

– Hemoglobin A1c equal or above 6.5%

– Active treatment with oral antidiabetic medications

– History of severe cardiac disease (e.g., angina, myocardial infarction, or cardiac
surgery) in the preceding year

– Significant systemic illness likely to result in deterioration of the patient’s
condition or, in the Investigator’s opinion, affect the patient’s safety during the
study, including in particular:

1. History of pancreatitis

2. Personal or family history of medullary thyroid carcinoma

3. History of multiple endocrine neoplasia syndrome type 2

4. History of alcoholism

5. Severe gastrointestinal disease, including gastroparesis

6. Treatment with immunosuppressive medications (e.g., systemic corticosteroids)
within the last 90 days or chemotherapeutic agents for malignancy within the last
2 years

7. Severe renal insufficiency (CrCl <30) 8. Moderate or severe hepatic impairment 9. Severe hypertriglyceridemia (triglycerides >500 mg/dl)

– Females who are pregnant or breast feeding

– Prior serious hypersensitivity reaction to Victoza or any of the product components
10) Body Mass Index <18.5

Locations

  • Cedars Sinai Medical Center, Los Angeles, California, United States, 90048
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