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Trial record 18 of 91 for:    "Brain Diseases" AND "Multiple System Atrophy"

Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.

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ClinicalTrials.gov Identifier: NCT02064166
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Novak, University of Massachusetts, Worcester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson Disease
Multiple System Atrophy
Intervention Drug: Intranasal Insulin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Insulin Placebo
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Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily

Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;

Placebo arm using intranasal normal saline

Placebo arm: normal saline, daily, intranasally, for 4 weeks.

Period Title: Overall Study
Started 9 6
Completed 8 6
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Insulin Placebo Total
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40 IU of intranasal insulin daily

Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.

Placebo arm using intranasal normal saline

Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 8 6 14
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  62.5%
3
  50.0%
8
  57.1%
>=65 years
3
  37.5%
3
  50.0%
6
  42.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 14 participants
63.4  (5.7) 62.2  (9.6) 62.9  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Female
3
  37.5%
3
  50.0%
6
  42.9%
Male
5
  62.5%
3
  50.0%
8
  57.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 6 participants 14 participants
8
 100.0%
6
 100.0%
14
 100.0%
1.Primary Outcome
Title Change in Verbal Fluency FAS (F, A or S Words) Total Score
Hide Description Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency.
Time Frame Baseline and post-treatment
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[Not Specified]
Arm/Group Title Insulin Baseline Insulin Post Treatment Placebo Baseline Placebo Post Treatment
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FAS score in the insulin group at baseline Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;

FAS score in the insulin group post treatment

Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;

FAS score in the placebo group at baseline Placebo arm using intranasal normal saline

Placebo arm: normal saline, daily, intranasally, for 4 weeks.

FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
Overall Number of Participants Analyzed 8 8 6 6
Mean (Standard Deviation)
Unit of Measure: Words
38.8  (5.7) 41.0  (8.2) 32.8  (2.3) 30.8  (7.1)
2.Secondary Outcome
Title Modified Hoehn and Yahr Scale
Hide Description The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism.
Time Frame Baseline and post-treatment
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[Not Specified]
Arm/Group Title Insulin Baseline Insulin Post Treatment Placebo Baseline Placebo Post Treatment
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HY Scale in the insulin group at baseline
HY scale in the insulin group post treatment
HY scale in placebo group at baseline
HY scale in placebo group post treatment
Overall Number of Participants Analyzed 8 8 6 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.0  (0.6) 2.0  (0.7) 2.4  (0.38) 2.4  (0.2)
3.Secondary Outcome
Title Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)
Hide Description The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal.
Time Frame Baseline and post-treatment
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[Not Specified]
Arm/Group Title Insulin Baseline Insulin Post Treatment Placebo Baseline Placebo Post Treatment
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MOCA Scale in insulin group at baseline
MOCA scale in insulin group post treatment
MOCA score in the placebo group at baseline
MOCA score in the placebo group post treatment
Overall Number of Participants Analyzed 8 8 6 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
28.7  (1.2) 28.0  (1.1) 26.8  (2.6) 28.2  (0.95)
4.Secondary Outcome
Title Beck Depression Inventory Score (BDI)
Hide Description Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.
Time Frame Baseline and post-treatment
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[Not Specified]
Arm/Group Title Insulin Baseline Insulin Post Treatment Placebo Baseline Placebo Post Treatment
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BDI Scale in the insulin group at baseline
BDI scale in the insulin group post-treatment
BDI score in the placebo group at baseline
BDI score in the placebo group post treatment
Overall Number of Participants Analyzed 8 8 6 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.8  (5.4) 8.25  (8.1) 13.5  (5.6) 12.8  (7.4)
5.Other Pre-specified Outcome
Title Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)
Hide Description UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups.
Time Frame Baseline and post-treatment
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[Not Specified]
Arm/Group Title Insulin Baseline Insulin Post Treatment Placebo Baseline Placebo Post Treatment
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UPDRS III Scale in the insulin group at baseline
UPDRS III Scale in the insulin group at post treatment
UPDRS III Scale in the placebo group at baseline
UPDRS III Scale in the insulin group post treatment
Overall Number of Participants Analyzed 8 8 6 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
31.5  (20.0) 25.6  (21.8) 31.7  (13.3) 30.5  (15.8)
6.Other Pre-specified Outcome
Title Gait Analysis (4-meter Test)
Hide Description Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment.
Time Frame Baseline and post-treatment
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[Not Specified]
Arm/Group Title Insulin Baseline Insulin Post Treatment Placebo Baseline Placebo Post Treatment
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Stride interval in the insulin group at baseline
Stride interval in the insulin group post treatment
Stride interval in placebo group at baseline
Stride interval in placebo group post treatment
Overall Number of Participants Analyzed 8 8 6 6
Mean (Standard Deviation)
Unit of Measure: inch
22.0  (5.0) 21.5  (4.4) 21.0  (2.7) 19.6  (2.9)
7.Other Pre-specified Outcome
Title Brief Visuospatial Memory Test-Revised (BVMT-R)
Hide Description Changes in Brief Visuospatial Memory Test-Revised (BMVT-R) compared to baseline. For BVMT, there were concerns about the test administration and validity of this test which relies on fine motor control in PD patients that have motor impairment which could affect the drawing precision. Therefore, BVMT was not included in the analyses, because these methodological concerns would have affected the calculation of the total score as the outcome measure.
Time Frame Baseline and post-treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Placebo
Hide Arm/Group Description 40 IU of intranasal insulin daily Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks. Placebo arm using intranasal normal saline Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.
All-Cause Mortality
Insulin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/6 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Pneumonia   1/9 (11.11%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Novak, MD PhD
Organization: Brigham & Women's Hospital
Phone: 617-732-8896
EMail: pnovak2@bwh.harvard.edu
Layout table for additonal information
Responsible Party: Peter Novak, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02064166     History of Changes
Other Study ID Numbers: PN-1
First Submitted: February 13, 2014
First Posted: February 17, 2014
Results First Submitted: May 23, 2018
Results First Posted: November 22, 2018
Last Update Posted: November 22, 2018