Trial · Interventional

CompletedPhase 2Results postedRegistry data

Safety and Efficacy of Liraglutide in Parkinson's Disease

NCTNCT02953665Other idU1111-1173-0106

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 63 participants (actual)
Sponsor: Cedars-Sinai Medical Center · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 3 Apr 2017
Primary completion: 3 Aug 2022
Completion: 3 Aug 2022
First posted: 3 Nov 2016 (estimated)
Last update posted: 7 Mar 2024
Conditions: Parkinson Disease

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2017201820192020202120222023

Ph 2
Safety and Efficacy of Liraglutide in Parkinson's Disease
NCT02953665
3 Apr 2017 to 3 Aug 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

LiraglutideDrug
PlaceboDrug

Arms2

Active comparator
Liraglutide
Liraglutide 6 mg/ml (Novo Nordisk A/S) will be self-administered subcutaneously once daily at a maximum dose of 1.8 mg after a 2 week titration schedule.
Placebo comparator
Placebo
Placebo will be self-administered subcutaneously once daily according to the same schedule.

Primary outcomes3

Outcomes the sponsor listed as 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
Time frame · From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)
Registry description
The UPDRS Part III (motor symptoms sub-scale) Assessment consists of 17 items, measured on a 5-Point scale (0-Normal to 4-Severe), addressing speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The participant's score is calculated as a sum of the scores of the 17 individual questions. This sum score ranges from 0 to 108. Higher scores denote greater disability. A participant has been considered "OFF" when he/she has been off L-dopa for greater than 12 hours. During "OFF" time, the participant will not report feeling the effects of their anti-Parkinson's medication. The participant recorded the exact time of L-dopa intake. Assessment was only conducted greater than 12 hours after dosing with the participant reportedly feeling "OFF."
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)
Registry description
The NMSS is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease. The NMSS measures severity and frequency of non-motor symptoms across nine dimensions (cardiovascular, sleep/fatigue, mood/apathy, perceptual problems/hallucinations, attention/memory, gastrointestinal, urinary, sexual function, and miscellaneous which includes pain, taste/smell, weight change, and excessive sweating). Higher scores indicate a higher burden of these symptoms on the patient. There are 30 items to be scored, and the item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.
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)
Registry description
The DRS-2 assesses individuals in five areas resulting in five sub-scale scores. These scores are used to determine the overall score and level of cognitive functioning ability. The five areas include: Attention - measured using eight items Construction - measured using six items Conceptualization - measured using six items Initiation/Preservation - measured using eleven items Memory - measured using five items Higher raw scores indicate better cognitive status, with scores ranging from 0 to 144. Normative data in healthy subjects range from 137 to 144.

Secondary outcomes(3)

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)
Registry description
Peripheral insulin resistance was assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index. The HOMA-IR tool is a validated, non-invasive tool to assess the relationship between glucose and insulin. A score less than 1 means indicates insulin-sensitivity (Optimal). Greater than 1.9 indicates early insulin resistance, and a score greater than 2.9 indicates significant insulin resistance. An increase in one's HOMA-IR score may indicate increased insulin resistance.
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)
Registry description
Total UPDRS Score (Parts I, II, III, and IV; administered in the ON condition) Change from Baseline to End of Maintenance Period. UPDRS I evaluation of mentation, behavior, and mood UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food UPDRS III clinician-scored monitored motor evaluation UPDRS IV evaluation of complications in therapy and motor fluctuations, including OFF time and dyskinesia The UPDRS I, II, III, and IV scores and subscores are calculated as the sum of all individual items. Subscales have 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe The final cumulative score will range from 0 (no disability) to 260 (total disability). A decrease in the mean indicates global improvement in the UPDRS score.
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)
Registry description
The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item patient-reported rating scale that measures Parkinson's disease-specific health related quality of life. It covers 8 areas: mobility, activities of daily living (ADL), emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Lower scores indicate better health related quality of life. PDQ-39 total scores range from 0 to 800. The total score can be summarised into the PDQ-39 summary index score (range of scores 0 to 100). A mean change in the PDQ-39 summary index score of about 1.6 points relates to feeling 'a little worse' and is likely to represent a clinically important difference.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From Baseline (Week 0) to 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

Group	Value (units on a scale)	Spread
Full Analysis Set (Liraglutide-treated Subjects)	-2.3	9.4
Full Analysis Set (Placebo-treated Subjects)	-5.0	7.1

Primary outcomeMean· From Baseline (Week 0) to the End of Maintenance Period (up to Week 54)

Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Period

Group	Value (units on a scale)	Spread
Full Analysis Set (Liraglutide-treated Subjects)	-5.5	25.3
Full Analysis Set (Placebo-treated Subjects)	6.5	21.3

Primary outcomeMean· From Baseline (Week 0) to the end of Maintenance Period (up to 54 weeks)

Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Period

Group	Value (units on a scale)	Spread
Full Analysis Set (Liraglutide-treated Subjects)	1.4	9.3
Full Analysis Set (Placebo-treated Subjects)	-0.3	9.1

Secondary and other outcome results(3)

Secondary outcomeMean· From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Period

Group	Value (units on a scale)	Spread
Full Analysis Set (Liraglutide-treated Subjects)	0.1	1.1
Full Analysis Set (Placebo-treated Subjects)	0.3	0.8

Secondary outcomeMean· 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

Group	Value (units on a scale)	Spread
Full Analysis Set (Liraglutide-treated Subjects)	-4.9	12.7
Full Analysis Set (Placebo-treated Subjects)	2.3	10.4

Secondary outcomeMean· 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

Group	Value (units on a scale)	Spread
Full Analysis Set (Liraglutide-treated Subjects)	-2.5	9.9
Full Analysis Set (Placebo-treated Subjects)	11.2	14.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LiraglutideLiraglutide 6 mg/ml (Novo Nordisk A/S) self-administered subcutaneously once daily at a maximum dose of 1.8 mg after a 2 week titration schedule. Liraglutide: Liraglutide 6 mg/ml once daily at a maximum dose of 1.8 mg	0 / 42	9 / 42	42 / 42
PlaceboMatching Placebo self-administered subcutaneously once daily according to the same schedule. Placebo: Placebo (for Liraglutide) 6 mg/ml once daily at a maximum dose of 1.8 mg	0 / 21	2 / 21	18 / 21

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2020

6 results

The Novel Dual GLP-1/GIP Receptor Agonist DA-CH5 Is Superior to Single GLP-1 Receptor Agonists in the MPTP Model of Parkinson's Disease.

Zhang et al. 2020Journal of Parkinson's diseasecited by 60

PMID 31958096DOI 10.3233/jpd-191768PUB-31958096

Full text at the publisher6 results

Publisher page See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 25 Years up to 85 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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