NCT04687878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

December 28, 2020

Last Update Submit

April 22, 2024

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseInsulinIntranasalMotor symptomsNon-motor symptoms

Outcome Measures

Primary Outcomes (1)

  • 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.

    Base line, 4, 8 and 12 weeks after intervention

Secondary Outcomes (7)

  • Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II

    Base line, 4, 8 and 12 weeks after intervention

  • Disease severity

    Base line, 4, 8 and 12 weeks after intervention

  • Risk of Falling

    Base line, 4, 8 and 12 weeks after intervention

  • Cognitive score

    Base line, 4, 8 and 12 weeks after intervention

  • Depression score

    Base line, 4, 8 and 12 weeks after intervention

  • +2 more secondary outcomes

Study Arms (2)

Insulin

EXPERIMENTAL

Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks

Drug: Insulin

Placebo

PLACEBO COMPARATOR

Normal saline, twice a day, intranasally, every day for 12 weeks

Drug: Normal saline

Interventions

InsulinDRUG

20 IU twice a day, intranasally, every day for 12 weeks

Also known as: Insulin regular
Insulin
Normal salineDRUG

twice a day, intranasally, every day for 12 weeks

Placebo

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital

Tehran, Iran

Location

MeSH Terms

Conditions

Parkinson DiseaseInsulin Resistance

Interventions

InsulinSaline Solution

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Leila Dargahi, PharmD/PhD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Mehri Salari, MDFellowship

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Abolhassan Ahmadiani, PharmD/PhD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Neda Valian, PhD

    Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

  • Leila Mohaghegh Shalmani, PharmD/PhD

    Shahid Beheshti University of Medical Sciences

    STUDY CHAIR

  • Helia Ashourizadeh, Intern

    Shahid Beheshti University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 29, 2020

Study Start

January 1, 2020

Primary Completion

June 20, 2022

Study Completion

September 20, 2023

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

IR(1)