Parkinson DiseasePhase 2NCT04687878
The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients
A Phase 2 study testing Insulin and Normal saline in people with Parkinson Disease, run by dr.dargahi at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Insulin and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2020to 20 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
Tehran
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Insulin, Normal saline
- Keywords
- Parkinson's disease, Insulin, Intranasal, Motor symptoms, Non-motor symptoms
- Medical subject headings
- Parkinson Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Insulin regular
20 IU twice a day, intranasally, every day for 12 weeks
Normal salineDrug
twice a day, intranasally, every day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Experimental | Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks Receives: Drug: Insulin |
| Placebo | Placebo comparator | Normal saline, twice a day, intranasally, every day for 12 weeks Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Base line, 4, 8 and 12 weeks after intervention
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.
Measured: Base line, 4, 8 and 12 weeks after intervention
Risk of Falling
Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling.
Measured: Base line, 4, 8 and 12 weeks after intervention
Cognitive score
The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance.
Measured: Base line, 4, 8 and 12 weeks after intervention
Depression score
Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression.
Measured: Base line, 4, 8 and 12 weeks after intervention
Anxiety score
Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety.
Measured: Base line, 4, 8 and 12 weeks after intervention
Fatigue score
Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue.
Measured: Base line, 4, 8 and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2020
- Primary completion20 Jun 2022
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr.dargahi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr.dargahi, Shahid Beheshti University of Medical Sciences
- Investigators
- Leila Dargahi, PharmD/PhD, Principal investigator, Shahid Beheshti University of Medical SciencesMehri Salari, MDFellowship, Principal investigator, Shahid Beheshti University of Medical SciencesAbolhassan Ahmadiani, PharmD/PhD, Principal investigator, Shahid Beheshti University of Medical SciencesNeda Valian, PhD, Study director, Shahid Beheshti University of Medical SciencesLeila Mohaghegh Shalmani, PharmD/PhD, Study chair, Shahid Beheshti University of Medical SciencesHelia Ashourizadeh, Intern, Study chair, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687878
- Sponsor's protocol ID
- IR.SBMU.PHNS.REC.1398.094
- Status last verified
- Apr 2024
- First submitted
- 28 Dec 2020
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04687878
- Acronym / sponsor ID
- IR.SBMU.PHNS.REC.1398.094
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Insulin, Intranasal, Motor symptoms, Non-motor symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- dr.dargahiUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Experimental | Drug: InsulinRegular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks |
| Placebo | Placebo comparator | Drug: Normal salineNormal saline, twice a day, intranasally, every day for 12 weeks |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinAlso: Insulin regular20 IU twice a day, intranasally, every day for 12 weeks | Drug | Insulin |
| Normal salinetwice a day, intranasally, every day for 12 weeks | Drug | Placebo |
Primary outcome
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
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.
7 secondary outcomes
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
Disease severity
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
Cognitive score
Time frame: Base line, 4, 8 and 12 weeks after intervention
Depression score
Time frame: Base line, 4, 8 and 12 weeks after intervention
Anxiety 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Dargahi, PharmD/PhD principal investigator
Shahid Beheshti University of Medical Sciences
Mehri Salari, MDFellowship principal investigator
Shahid Beheshti University of Medical Sciences
Abolhassan Ahmadiani, PharmD/PhD principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin and Normal saline in people with Parkinson Disease, run by dr.dargahi at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.