Trial Outcomes & Findings for Altropane Dose for Imaging Patients With Suspected Parkinson's Disease (NCT NCT05636852)
NCT ID: NCT05636852
Last Updated: 2025-07-15
Results Overview
Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers).
TERMINATED
PHASE2
15 participants
Day 1, up to 30 minutes
2025-07-15
Participant Flow
This study was conducted between 24 April 2023 to 08 June 2024 at 4 centers in the United States.
A total of 15 eligible participants entered in Part 1 of study. 13 participants received a single dose of Altropane. Two subjects were not dosed due to scheduling issues. The study was planned to be conducted in 2 parts. However, due to business decisions the sponsor terminated the study after completion of Part 1. This decision was not due to safety concerns.
Participant milestones
| Measure |
Part 1: Altropane (123I) Injection
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 independent expert blinded readers.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
Safety Set
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13
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Overall Study
Full Analysis Set
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10
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Part 1: Altropane (123I) Injection
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 independent expert blinded readers.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Other than specified
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1
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Baseline Characteristics
Altropane Dose for Imaging Patients With Suspected Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Part 1: Altropane (123I) Injection
n=13 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 independent expert blinded readers.
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|---|---|
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Age, Continuous
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66.2 years
STANDARD_DEVIATION 8.90 • n=5 Participants
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|
Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1, up to 30 minutesPopulation: Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation.
Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers).
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=10 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Reader 3
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90 percentage of participants
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Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Reader 1
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60 percentage of participants
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Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Reader 2
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80 percentage of participants
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Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Reader 4
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70 percentage of participants
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Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Reader 5
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80 percentage of participants
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Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Majority Readers
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80 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, up to 30 minutesPopulation: Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation.
Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers evaluated their confidence in striatal visualization, rating it as high, medium, or low. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the high and medium/low groupings. Percentage of participants with confidence ratings for 5-mCi Altropane images are reported.
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=10 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 1 : High
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40 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 1 : Medium
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40 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 1 : Low
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20 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 2 : High
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80 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 2 : Medium
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20 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 2 : Low
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0 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 3 : High
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70 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 3 : Medium
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30 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 3 : Low
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0 percentage of participants
|
|
Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 4 : High
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90 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 4 : Medium
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10 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 4 : Low
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0 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 5 : High
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50 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 5 : Medium
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40 percentage of participants
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Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Reader 5 : Low
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10 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, up to 30 minutesPopulation: Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation.
Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers assessed image quality as excellent, good, fair, poor, or unevaluable. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the excellent/good and fair/poor/unevaluable groupings. Percentage of participants with image quality for 5-mCi Altropane images are reported.
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=10 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 1 : Excellent
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90 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 1 : Good
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0 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 1 : Fair
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10 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 1 : Unevaluable
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0 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 2 : Excellent
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70 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 2 : Good
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30 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 2 : Fair
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0 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 2 : Unevaluable
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0 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 3 : Excellent
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80 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 3 : Good
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20 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 3 : Fair
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0 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 3 : Unevaluable
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0 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 4 : Excellent
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60 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 4 : Good
|
40 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 4 : Fair
|
0 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 4 : Unevaluable
|
0 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 5 : Excellent
|
20 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 5 : Good
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50 percentage of participants
|
|
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 5 : Fair
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30 percentage of participants
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Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Reader 5 : Unevaluable
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0 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, up to 30 minutesPopulation: Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation.
Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each subject's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Percentage of participants with inter-reader agreement on striatal visualization classification for whom 5, 4, and 3 readers, respectively, were in agreement on the participants classification (normal images) are reported.
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=10 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Inter-Reader Agreement on Percentage of Participants With Normal Images
5 Readers in Agreement
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70 percentage of participants
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Inter-Reader Agreement on Percentage of Participants With Normal Images
4 Readers in Agreement
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20 percentage of participants
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Inter-Reader Agreement on Percentage of Participants With Normal Images
3 Readers in Agreement
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10 percentage of participants
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SECONDARY outcome
Timeframe: From administration of Altropane until 24 hours post dosePopulation: Safety Analysis Set consisted of all participants who received a single dose of Altropane.
An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as AEs that started or worsened between the start of pharmaceutical product administration and the end of the follow-up period.
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=13 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
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23.1 percentage of participants
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SECONDARY outcome
Timeframe: From administration of Altropane until 24 hours post dosePopulation: Safety Analysis Set consisted of all participants who received a single dose of Altropane.
ADR is an AE that is caused by the investigational medicinal product.
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=13 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With Adverse Drug Reaction (ADR)
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0 percentage of participants
|
SECONDARY outcome
Timeframe: From administration of Altropane until 24 hours post dosePopulation: Safety Analysis Set consisted of all participants who received a single dose of Altropane.
Percentage of participants with clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature). Normal limits of vital signs are: 1. Systolic BP (mmHg) - low: 85 and High: 139; Diastolic BP (mmHg) - low: 60 and High: 89. 2. Heart rate (bpm) - low: 60 and High: 100. 3. Respiration Rate (rpm) - low: 12 and High: 22. 4. Body Temperature - low: 36.4 degree Celsius (97.5 degree Fahrenheit) and High: 37.7 degree Celsius (99.5 degree Fahrenheit).
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=13 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From administration of Altropane until 24 hours post dosePopulation: Safety Analysis Set consisted of all participants who received a single dose of Altropane.
Percentage of participants with clinically significant changes from baseline in physical examination (general appearance, lungs and heart).
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=13 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With Clinically Significant Changes From Baseline in Physical Examination Until 24 Hours Post Dose
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From administration of Altropane until 24 hours post dosePopulation: Safety Analysis Set consisted of all participants who received a single dose of Altropane.
Percentage of participants with clinically significant changes from baseline in electrocardiogram (ECG) examinations: (PR interval, QTc, QRS and RR interval). The normal limits (ms) of ECG variables: 1. PR interval (ms) - low: 120 and high: 200 2. QRS interval (ms) - low: 50 and high: 100 3. QTc interval (ms)- high =\<440 4. RR interval (ms) - low: 600 and high: 1000
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=13 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Examinations (PR Interval, QTc, QRS and RR Interval) Until 24 Hours Post Dose
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From administration of Altropane until 24 hours post dosePopulation: Safety Analysis Set consisted of all participants who received a single dose of Altropane.
Percentage of participants with clinically significant changes from baseline in serum biochemistry (Alanine aminotransferase, Albumin, Alkaline phosphatase, Bicarbonate, Creatine phosphokinase (CPK), total Creatinine, Protein (total), Phosphorous Glucose) and hematology parameters (Red blood cell (RBC) count, Platelet count, White blood cell (WBC) count).
Outcome measures
| Measure |
Part 1: Altropane (123I) Injection
n=13 Participants
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Percentage of Participants With Clinically Significant Changes From Baseline in Serum Biochemistry and Hematology Parameters Until 24 Hours Post Dose
|
0 percentage of participants
|
Adverse Events
Part 1: Altropane (123I) Injection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Altropane (123I) Injection
n=13 participants at risk
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
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|---|---|
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Injury, poisoning and procedural complications
Procedural complication
|
7.7%
1/13 • Number of events 1 • From administration of Altropane until 24 hours post dose
Safety Analysis Set consisted of all participants who received a single dose of Altropane.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
7.7%
1/13 • Number of events 1 • From administration of Altropane until 24 hours post dose
Safety Analysis Set consisted of all participants who received a single dose of Altropane.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
1/13 • Number of events 1 • From administration of Altropane until 24 hours post dose
Safety Analysis Set consisted of all participants who received a single dose of Altropane.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • From administration of Altropane until 24 hours post dose
Safety Analysis Set consisted of all participants who received a single dose of Altropane.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place