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Register:	ClinicalTrials.gov
Last refreshed on:	6 May 2024
Main ID:	NCT04687878
Date of registration:	28/12/2020
Prospective Registration:	No
Primary sponsor:	dr.dargahi
Public title:	The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients
Scientific 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
Date of first enrolment:	January 1, 2020
Target sample size:	28
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT04687878
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
Iran, Islamic Republic of

Contacts

Name:	Helia Ashourizadeh, Intern
Address:
Telephone:
Email:
Affiliation:	Shahid Beheshti University of Medical Sciences

Name:	Leila Dargahi, PharmD/PhD
Address:
Telephone:
Email:
Affiliation:	Shahid Beheshti University of Medical Sciences

Name:	Leila Mohaghegh Shalmani, PharmD/PhD
Address:
Telephone:
Email:
Affiliation:	Shahid Beheshti University of Medical Sciences

Name:	Neda Valian, PhD
Address:
Telephone:
Email:
Affiliation:	Shahid Beheshti University of Medical Sciences

Name:	Abolhassan Ahmadiani, PharmD/PhD
Address:
Telephone:
Email:
Affiliation:	Shahid Beheshti University of Medical Sciences

Name:	Mehri Salari, MDFellowship
Address:
Telephone:
Email:
Affiliation:	Shahid Beheshti University of Medical Sciences

Key inclusion & exclusion 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

Age minimum: 17 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Insulin

Drug: Normal saline

Primary Outcome(s)

Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Secondary Outcome(s)

Depression score [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Cognitive score [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Fatigue score [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Risk of Falling [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Disease severity [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Anxiety score [Time Frame: Base line, 4, 8 and 12 weeks after intervention]

Secondary ID(s)

IR.SBMU.PHNS.REC.1398.094

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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