Mode
Text Size
Log in / Sign up
Phase 2 Completed N=63 Randomized Quadruple-blind Treatment

Safety and Efficacy of Liraglutide in Parkinson's Disease

Source: ClinicalTrials.gov NCT02953665 ↗
Enrolled (actual)
63
Serious AEs
17.5%
Results posted
Mar 2024
Primary outcomePrimary: 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 — -2.3; -5.0 units on a scale

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
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
-2.3; -5.0
PRIMARY
Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Period
-5.5; 6.5
PRIMARY
Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Period
1.4; -0.3
SECONDARY
Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Period
0.1; 0.3
SECONDARY
Change in the Unified Parkinson's Disease Rating Scale Total Score From Baseline to the End of Double-Blind Maintenance Period
-4.9; 2.3
SECONDARY
Change in The Parkinson's Disease Questionnaire (PDQ-39) From Baseline to the End of Double-Blind Maintenance Period
-2.5; 11.2

Eligibility 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:
  • History of pancreatitis
  • Personal or family history of medullary thyroid carcinoma
  • History of multiple endocrine neoplasia syndrome type 2
  • History of alcoholism
  • Severe gastrointestinal disease, including gastroparesis
  • Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within the last 90 days or chemotherapeutic agents for malignancy within the last 2 years
  • Severe renal insufficiency (CrCl 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02953665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search