Trial Outcomes & Findings for Study of Parkinson's Early Stage With Deferiprone (NCT NCT02728843)
NCT ID: NCT02728843
Last Updated: 2024-04-10
Results Overview
Change from baseline to Month 9 in the score for the Part III subscale (motor examination) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 132 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
Nine months
Results posted on
2024-04-10
Participant Flow
Participant milestones
| Measure |
Placebo
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
28
|
28
|
28
|
|
Overall Study
COMPLETED
|
25
|
23
|
20
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
8
|
6
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
4
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Use of rescue medication
|
0
|
2
|
0
|
2
|
1
|
Baseline Characteristics
Study of Parkinson's Early Stage With Deferiprone
Baseline characteristics by cohort
| Measure |
300 mg
n=27 Participants
Patients took 300 mg deferiprone twice daily, for a total daily dosage of 600 mg
|
600 mg
n=26 Participants
Patients took 600 mg deferiprone twice daily, for a total daily dosage of 1200 mg
|
900 mg
n=25 Participants
Patients took 900 mg deferiprone twice daily, for a total daily dosage of 1800 mg
|
1200 mg
n=28 Participants
Patients took 1200 mg deferiprone twice daily, for a total daily dosage of 2400 mg
|
Placebo
n=27 Participants
Depending on which dosage cohort they were in, patients took a number of placebo tablets that matched the number of tablets taken by patients receiving active product
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
61.9 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
61.4 years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
129 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
130 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
25 participants
n=10 Participants
|
|
Region of Enrollment
France
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
18 participants
n=5 Participants
|
21 participants
n=4 Participants
|
18 participants
n=21 Participants
|
93 participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
12 participants
n=10 Participants
|
|
MDS-UPDRS Total Score
|
29.7 units on a scale
STANDARD_DEVIATION 11.6 • n=5 Participants
|
31.1 units on a scale
STANDARD_DEVIATION 13.3 • n=7 Participants
|
29.8 units on a scale
STANDARD_DEVIATION 12.3 • n=5 Participants
|
24.5 units on a scale
STANDARD_DEVIATION 10.7 • n=4 Participants
|
27.4 units on a scale
STANDARD_DEVIATION 12.3 • n=21 Participants
|
28.4 units on a scale
STANDARD_DEVIATION 12.1 • n=10 Participants
|
|
MDS-UPDRS Part I
|
6.2 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 3.0 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 2.4 • n=4 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 3.1 • n=21 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 3.2 • n=10 Participants
|
|
MDS-UPDRS Part II
|
4.1 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 3.1 • n=4 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 4.0 • n=21 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 4.0 • n=10 Participants
|
|
MDS-UPDRS Part III
|
19.1 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
19.4 units on a scale
STANDARD_DEVIATION 10.4 • n=7 Participants
|
18.1 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 8.5 • n=4 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 9.1 • n=21 Participants
|
17.6 units on a scale
STANDARD_DEVIATION 8.8 • n=10 Participants
|
|
MDS-UPDRS Part II/Part III
|
23.2 units on a scale
STANDARD_DEVIATION 10.1 • n=5 Participants
|
25.2 units on a scale
STANDARD_DEVIATION 12.4 • n=7 Participants
|
23.8 units on a scale
STANDARD_DEVIATION 10.8 • n=5 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 9.9 • n=4 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 10.6 • n=21 Participants
|
22.7 units on a scale
STANDARD_DEVIATION 10.8 • n=10 Participants
|
|
MDS-UPDRS Part IV
|
0.2 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
0.2 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
0.1 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.2 units on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants
|
0.0 units on a scale
STANDARD_DEVIATION 0.2 • n=21 Participants
|
0.2 units on a scale
STANDARD_DEVIATION 0.7 • n=10 Participants
|
|
Montreal Cognitive Assessment
|
27.7 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
28.1 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
27.3 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
27.1 units on a scale
STANDARD_DEVIATION 1.9 • n=21 Participants
|
27.6 units on a scale
STANDARD_DEVIATION 1.8 • n=10 Participants
|
PRIMARY outcome
Timeframe: Nine monthsPopulation: Intent-to-treat (ITT) population
Change from baseline to Month 9 in the score for the Part III subscale (motor examination) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 132 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.
Outcome measures
| Measure |
Placebo
n=27 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=27 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=26 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=25 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Change in Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
|
2.1 Score on a scale
Standard Error 1.4
|
4.2 Score on a scale
Standard Error 1.4
|
-0.8 Score on a scale
Standard Error 1.5
|
3.9 Score on a scale
Standard Error 1.5
|
2.2 Score on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Nine monthsPopulation: ITT population
Change from baseline to Month 9 in total score on the MDS-UPDRS. The total score can range from 0 (best) to 260 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.
Outcome measures
| Measure |
Placebo
n=27 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=27 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=26 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=25 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Change in Total Score on the MDS-UPDRS
|
4.1 Score on a scale
Standard Error 1.9
|
7.8 Score on a scale
Standard Error 1.9
|
0.5 Score on a scale
Standard Error 2.1
|
6.6 Score on a scale
Standard Error 2.1
|
5.9 Score on a scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Nine monthsPopulation: ITT population
Change from baseline to Month 9 in the score for the Part I subscale (mentation, behavior, and mood) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.
Outcome measures
| Measure |
Placebo
n=27 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=27 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=26 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=25 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Change in Score on the Part I Subscale of the MDS-UPDRS
|
0.8 Score on a scale
Standard Error 0.7
|
1.0 Score on a scale
Standard Error 0.7
|
0.3 Score on a scale
Standard Error 0.7
|
0.3 Score on a scale
Standard Error 0.7
|
1.1 Score on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Nine monthsPopulation: ITT population
Change from baseline to Month 9 in the score for the Part II subscale (activities of daily living) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.
Outcome measures
| Measure |
Placebo
n=27 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=27 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=26 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=25 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Change in Score on the Part II Subscale of the MDS-UPDRS
|
1.1 Score on a scale
Standard Error 0.6
|
2.2 Score on a scale
Standard Error 0.6
|
0.6 Score on a scale
Standard Error 0.6
|
2.1 Score on a scale
Standard Error 0.6
|
1.8 Score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Nine monthsPopulation: ITT population
Change from baseline to Month 9 in the score for the Part IV subscale (motor complications) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 24 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.
Outcome measures
| Measure |
Placebo
n=27 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=27 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=26 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=25 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Change in Score in the Part IV Subscale of the MDS-UPDRS
|
-0.1 Score on a scale
Standard Error 0.2
|
0.2 Score on a scale
Standard Error 0.2
|
0.3 Score on a scale
Standard Error 0.2
|
0.2 Score on a scale
Standard Error 0.2
|
0.4 Score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Nine monthsPopulation: ITT population
Change from baseline to Month 9 in the combined score for the Part II subscale (motor experiences of daily living) and the Part III subscale (motor examination) of the MDS-UPDRS. The scales for these two parts range from 0 (best) to 52 (worst) and from 0 (best) to 132 (worst), respectively. Hence, the combined score can range from 0 (best) to 184 (worst), and an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score is presented as least square means.
Outcome measures
| Measure |
Placebo
n=27 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=27 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=26 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=25 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Change in the Combined Scores From Parts II and III of the MDS-UPDRS
|
3.3 Score on a scale
Standard Error 1.6
|
6.5 Score on a scale
Standard Error 1.6
|
-0.3 Score on a scale
Standard Error 1.7
|
6.0 Score on a scale
Standard Error 1.7
|
4.3 Score on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Nine monthsPopulation: ITT population
Change from baseline to Month 9 in the score for overall cognitive function as assessed by the MoCA. The total score on the MoCA can range from 0 (worst) to 30 (best). Hence, a decrease in score would indicate progression of the disease and an increase would indicate improvement. The change in score is presented as least square means.
Outcome measures
| Measure |
Placebo
n=27 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=27 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=26 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=25 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Change in Score on the Montreal Cognitive Assessment (MoCA) Test
|
1.1 Score on a scale
Standard Error 0.3
|
1.0 Score on a scale
Standard Error 0.3
|
0.9 Score on a scale
Standard Error 0.3
|
1.1 Score on a scale
Standard Error 0.3
|
1.4 Score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Nine monthsPopulation: Safety population
Number of subjects with adverse events
Outcome measures
| Measure |
Placebo
n=28 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=28 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=28 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=28 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 Participants
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Safety of Deferiprone
|
26 Participants
|
25 Participants
|
23 Participants
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Pharmacokinetics (PK) population: Included all patients who had sufficient PK data to derive at least one PK parameter.
Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The maximum measured serum concentration (Cmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.
Outcome measures
| Measure |
Placebo
n=4 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=2 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=5 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=2 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Serum deferiprone
|
2.748 μg/mL
Standard Deviation 0.781
|
3.459 μg/mL
Standard Deviation 0.078
|
5.080 μg/mL
Standard Deviation 2.614
|
7.942 μg/mL
Standard Deviation 2.192
|
—
|
|
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Serum deferiprone 3-O-glucuronide
|
7.844 μg/mL
Standard Deviation 0.936
|
12.419 μg/mL
Standard Deviation 2.218
|
21.914 μg/mL
Standard Deviation 8.309
|
32.632 μg/mL
Standard Deviation 2.167
|
—
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Pharmacokinetics population: Included all patients who had sufficient PK data to derive at least one PK parameter.
Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The time to maximum observed serum concentration (Tmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.
Outcome measures
| Measure |
Placebo
n=4 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=2 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=5 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=2 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Serum deferiprone
|
2.00 Hours
Interval 1.67 to 2.33
|
2.17 Hours
Interval 2.0 to 2.33
|
2.00 Hours
Interval 0.58 to 2.67
|
1.67 Hours
Interval 1.33 to 2.0
|
—
|
|
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Serum deferiprone 3-O-glucuronide
|
2.84 Hours
Interval 2.33 to 3.0
|
3.25 Hours
Interval 3.0 to 3.5
|
3.50 Hours
Interval 2.67 to 3.58
|
2.50 Hours
Interval 2.33 to 2.67
|
—
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Pharmacokinetics population: Included all patients who had sufficient PK data to derive at least one PK parameter.
Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The total drug exposure, AUC0-∞ (area under the serum concentration time curve extrapolated to infinity) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.
Outcome measures
| Measure |
Placebo
n=4 Participants
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=1 Participants
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=5 Participants
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=2 Participants
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Area Under the Curve for Serum Deferiprone and Deferiprone 3-O-glucuronide
Serum deferiprone 3-O-glucuronide
|
39.057 μg*h/mL
Standard Deviation 7.820
|
62.679 μg*h/mL
|
121.128 μg*h/mL
Standard Deviation 43.727
|
147.397 μg*h/mL
Standard Deviation 6.502
|
—
|
|
Area Under the Curve for Serum Deferiprone and Deferiprone 3-O-glucuronide
Serum deferiprone
|
8.358 μg*h/mL
Standard Deviation 0.904
|
16.292 μg*h/mL
|
20.606 μg*h/mL
Standard Deviation 8.742
|
26.328 μg*h/mL
Standard Deviation 5.693
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Deferiprone 300 mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Deferiprone 600 mg
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Deferiprone 900 mg
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Deferiprone 1200 mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=28 participants at risk
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=28 participants at risk
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=28 participants at risk
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 participants at risk
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
|
Psychiatric disorders
Jealous delusion
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Placebo: Tablets that match the deferiprone tablets in appearance
|
Deferiprone 300 mg
n=28 participants at risk
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Deferiprone: 600 mg tablets
|
Deferiprone 600 mg
n=28 participants at risk
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Deferiprone: 600 mg tablets
|
Deferiprone 900 mg
n=28 participants at risk
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Deferiprone: 600 mg tablets
|
Deferiprone 1200 mg
n=28 participants at risk
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Deferiprone: 600 mg tablets
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
2/28 • Number of events 3 • 10 months
|
3.6%
1/28 • Number of events 4 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Ear and labyrinth disorders
Vertigo
|
3.6%
1/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Eye disorders
Cataract
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
3/28 • Number of events 3 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
25.0%
7/28 • Number of events 8 • 10 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Number of events 1 • 10 months
|
14.3%
4/28 • Number of events 4 • 10 months
|
17.9%
5/28 • Number of events 5 • 10 months
|
7.1%
2/28 • Number of events 4 • 10 months
|
17.9%
5/28 • Number of events 5 • 10 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/28 • 10 months
|
14.3%
4/28 • Number of events 4 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
General disorders
Asthenia
|
0.00%
0/28 • 10 months
|
10.7%
3/28 • Number of events 4 • 10 months
|
7.1%
2/28 • Number of events 5 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
|
General disorders
Chest discomfort
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
General disorders
Chest pain
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
General disorders
Condition aggravated
|
3.6%
1/28 • Number of events 1 • 10 months
|
17.9%
5/28 • Number of events 8 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
21.4%
6/28 • Number of events 8 • 10 months
|
14.3%
4/28 • Number of events 5 • 10 months
|
|
General disorders
Fatigue
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
14.3%
4/28 • Number of events 6 • 10 months
|
|
General disorders
Gait disturbance
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
|
Infections and infestations
Gastroenteritis
|
10.7%
3/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
1/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
7.1%
2/28 • Number of events 5 • 10 months
|
17.9%
5/28 • Number of events 6 • 10 months
|
14.3%
4/28 • Number of events 4 • 10 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Number of events 2 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28 • Number of events 4 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 4 • 10 months
|
7.1%
2/28 • Number of events 17 • 10 months
|
0.00%
0/28 • 10 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Investigations
Amylase increased
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
|
Investigations
Blood urine present
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 5 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
3/28 • Number of events 3 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • Number of events 2 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
14.3%
4/28 • Number of events 7 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/28 • 10 months
|
14.3%
4/28 • Number of events 4 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • Number of events 1 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
10.7%
3/28 • Number of events 4 • 10 months
|
|
Nervous system disorders
Akinesia
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 2 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 6 • 10 months
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 6 • 10 months
|
21.4%
6/28 • Number of events 9 • 10 months
|
14.3%
4/28 • Number of events 4 • 10 months
|
17.9%
5/28 • Number of events 9 • 10 months
|
28.6%
8/28 • Number of events 29 • 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parkinson's disease
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Nervous system disorders
Sciatica
|
3.6%
1/28 • Number of events 1 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Number of events 1 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
|
Nervous system disorders
Tremor
|
3.6%
1/28 • Number of events 1 • 10 months
|
10.7%
3/28 • Number of events 3 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
21.4%
6/28 • Number of events 8 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
0.00%
0/28 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.7%
3/28 • Number of events 3 • 10 months
|
3.6%
1/28 • Number of events 1 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
3.6%
1/28 • Number of events 2 • 10 months
|
10.7%
3/28 • Number of events 4 • 10 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 3 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
|
Vascular disorders
Hypertension
|
14.3%
4/28 • Number of events 4 • 10 months
|
0.00%
0/28 • 10 months
|
0.00%
0/28 • 10 months
|
7.1%
2/28 • Number of events 2 • 10 months
|
0.00%
0/28 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60