Trial Outcomes & Findings for Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin. (NCT NCT02064166)
NCT ID: NCT02064166
Last Updated: 2018-11-23
Results Overview
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.
COMPLETED
PHASE2
15 participants
Baseline and post-treatment
2018-11-23
Participant Flow
Participant milestones
| Measure |
Insulin
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
Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Insulin
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
Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
Baseline characteristics by cohort
| Measure |
Insulin
n=8 Participants
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
n=6 Participants
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
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-treatmentChanges 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.
Outcome measures
| Measure |
Insulin Baseline
n=8 Participants
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;
|
Insulin Post Treatment
n=8 Participants
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;
|
Placebo Baseline
n=6 Participants
FAS score in the placebo group at baseline Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
Placebo Post Treatment
n=6 Participants
FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
|
|---|---|---|---|---|
|
Change in Verbal Fluency FAS (F, A or S Words) Total Score
|
38.8 Words
Standard Deviation 5.7
|
41.0 Words
Standard Deviation 8.2
|
32.8 Words
Standard Deviation 2.3
|
30.8 Words
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Baseline and post-treatmentThe 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.
Outcome measures
| Measure |
Insulin Baseline
n=8 Participants
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;
|
Insulin Post Treatment
n=8 Participants
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;
|
Placebo Baseline
n=6 Participants
FAS score in the placebo group at baseline Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
Placebo Post Treatment
n=6 Participants
FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
|
|---|---|---|---|---|
|
Modified Hoehn and Yahr Scale
|
2.0 score on a scale
Standard Deviation 0.6
|
2.0 score on a scale
Standard Deviation 0.7
|
2.4 score on a scale
Standard Deviation 0.38
|
2.4 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and post-treatmentThe 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.
Outcome measures
| Measure |
Insulin Baseline
n=8 Participants
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;
|
Insulin Post Treatment
n=8 Participants
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;
|
Placebo Baseline
n=6 Participants
FAS score in the placebo group at baseline Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
Placebo Post Treatment
n=6 Participants
FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
|
|---|---|---|---|---|
|
Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)
|
28.7 score on a scale
Standard Deviation 1.2
|
28.0 score on a scale
Standard Deviation 1.1
|
26.8 score on a scale
Standard Deviation 2.6
|
28.2 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline and post-treatmentBeck 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.
Outcome measures
| Measure |
Insulin Baseline
n=8 Participants
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;
|
Insulin Post Treatment
n=8 Participants
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;
|
Placebo Baseline
n=6 Participants
FAS score in the placebo group at baseline Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
Placebo Post Treatment
n=6 Participants
FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
|
|---|---|---|---|---|
|
Beck Depression Inventory Score (BDI)
|
7.8 score on a scale
Standard Deviation 5.4
|
8.25 score on a scale
Standard Deviation 8.1
|
13.5 score on a scale
Standard Deviation 5.6
|
12.8 score on a scale
Standard Deviation 7.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and post-treatmentUPDRS 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.
Outcome measures
| Measure |
Insulin Baseline
n=8 Participants
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;
|
Insulin Post Treatment
n=8 Participants
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;
|
Placebo Baseline
n=6 Participants
FAS score in the placebo group at baseline Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
Placebo Post Treatment
n=6 Participants
FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
|
|---|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)
|
31.5 score on a scale
Standard Deviation 20.0
|
25.6 score on a scale
Standard Deviation 21.8
|
31.7 score on a scale
Standard Deviation 13.3
|
30.5 score on a scale
Standard Deviation 15.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and post-treatmentChanges in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment.
Outcome measures
| Measure |
Insulin Baseline
n=8 Participants
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;
|
Insulin Post Treatment
n=8 Participants
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;
|
Placebo Baseline
n=6 Participants
FAS score in the placebo group at baseline Placebo arm using intranasal normal saline
Placebo arm: normal saline, daily, intranasally, for 4 weeks.
|
Placebo Post Treatment
n=6 Participants
FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
|
|---|---|---|---|---|
|
Gait Analysis (4-meter Test)
|
22.0 inch
Standard Deviation 5.0
|
21.5 inch
Standard Deviation 4.4
|
21.0 inch
Standard Deviation 2.7
|
19.6 inch
Standard Deviation 2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and post-treatmentChanges 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.
Outcome measures
Outcome data not reported
Adverse Events
Insulin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin
n=9 participants at risk
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
n=6 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place