Safety and Efficacy of Liraglutide in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT02953665
• Date of registration: 21/10/2016
• Prospective Registration: Yes
• Primary sponsor: Cedars-Sinai Medical Center
• Public title: Safety and Efficacy of Liraglutide in Parkinson's Disease
• Scientific title: A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease
• Date of first enrolment: April 3, 2017
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02953665
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Michele Tagliati, MD
• Affiliation: Cedars-Sinai Medical Center

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Placebo

Drug: Liraglutide

Primary Outcome(s)

Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Period [Time Frame: From Baseline (Week 0) to the End of Maintenance Period (up to Week 54)]

Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Period [Time Frame: From Baseline (Week 0) to the end of Maintenance Period (up to 54 weeks)]

Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "OFF" Time From Baseline to the End of Double-Blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)]

Secondary Outcome(s)

Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)]

Change in the Unified Parkinson's Disease Rating Scale Total Score From Baseline to the End of Double-Blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)]

Change in The Parkinson's Disease Questionnaire (PDQ-39) From Baseline to the End of Double-Blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)]

Secondary ID(s)

U1111-1173-0106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novo Nordisk A/S

The Cure Parkinson's Trust

Results

• Results available: Yes
• Date Posted: 07/03/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02953665