Back to resultsThe Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Insulin
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Insulin, Intranasal, Motor symptoms, Non-motor symptoms
Eligibility Criteria
Inclusion Criteria:
- Man and woman over 17 years old
- Patient with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
- Provide written informed consent to participate in the study.
- Understand that they may withdraw their consent at any time.
Exclusion Criteria:
- Pregnant and lactating women
- Patients with diabetes and taking anti-hyperglycemic drugs
- Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, Amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy, etc.
- Patients who cannot walk for more than one minute without help
- A history of allergic reaction to insulin
- The presence of inflammation of nasal cavity that may prevents absorption of insulin
Sites / Locations
- Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Insulin
Placebo
Arm Description
Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks
Normal saline, twice a day, intranasally, every day for 12 weeks
Outcomes
Primary Outcome Measures
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, IV assess the motor signs of Parkinson's Disease; higher score means more severity of the motor symptoms.
Secondary Outcome Measures
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II assess the non motor signs of PD; higher score means more severity of the symptoms.
Disease severity
The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson's Disease. The scale ranges from 1 to 5. The lower score indicates better outcome.
Risk of Falling
Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling.
Cognitive score
The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance.
Depression score
Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression.
Anxiety score
Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety.
Fatigue score
Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04687878
Brief Title
The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients
Official Title
Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
dr.dargahi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effect of intranasal insulin on motor and non-motor symptoms of patients with Parkinson's disease over a 12-week period.
Detailed Description
This study is a single-center, parallel and double-blind study. Patients with Parkinson's disease referred to Movement Clinic of Shohada-e-Tajrish Hospital will randomly receive intranasal placebo or insulin, every day, twice a day for 12 weeks. Motor and non-motor symptoms will be evaluated in four time points; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms (MDS-UPDRS; part III, IV), and secondary outcomes are motor (gait balance) and non-motor (MDS-UPDRS part I, II, cognition, depression, anxiety and fatigue) symptoms. Patients, researchers (physicians, outcome assessors) and data analysts are blinded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Insulin, Intranasal, Motor symptoms, Non-motor symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Insulin
Arm Type
Experimental
Arm Description
Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline, twice a day, intranasally, every day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Insulin regular
Intervention Description
20 IU twice a day, intranasally, every day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
twice a day, intranasally, every day for 12 weeks
Primary Outcome Measure Information:
Title
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV
Description
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, IV assess the motor signs of Parkinson's Disease; higher score means more severity of the motor symptoms.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
Secondary Outcome Measure Information:
Title
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II
Description
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II assess the non motor signs of PD; higher score means more severity of the symptoms.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
Title
Disease severity
Description
The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson's Disease. The scale ranges from 1 to 5. The lower score indicates better outcome.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
Title
Risk of Falling
Description
Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
Title
Cognitive score
Description
The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
Title
Depression score
Description
Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
Title
Anxiety score
Description
Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
Title
Fatigue score
Description
Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue.
Time Frame
Base line, 4, 8 and 12 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man and woman over 17 years old
Patient with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
Provide written informed consent to participate in the study.
Understand that they may withdraw their consent at any time.
Exclusion Criteria:
Pregnant and lactating women
Patients with diabetes and taking anti-hyperglycemic drugs
Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, Amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy, etc.
Patients who cannot walk for more than one minute without help
A history of allergic reaction to insulin
The presence of inflammation of nasal cavity that may prevents absorption of insulin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Dargahi, PharmD/PhD
Phone
+989125069930
Email
l.dargahi@sbmu.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Dargahi, PharmD/PhD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehri Salari, MDFellowship
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abolhassan Ahmadiani, PharmD/PhD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neda Valian, PhD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leila Mohaghegh Shalmani, PharmD/PhD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helia Ashourizadeh, Intern
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehri Salari, MDFelloship
Phone
+989124972186
Email
mehri.salari@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients
We'll reach out to this number within 24 hrs