Trial Outcomes & Findings for A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms (NCT NCT00382967)
NCT ID: NCT00382967
Last Updated: 2012-09-03
Results Overview
The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
273 participants
Primary outcome timeframe
Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)
Results posted on
2012-09-03
Participant Flow
Participant milestones
| Measure |
Datscan Product
\[Iodine-123\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \[3-5 millicurie (mCi)\].
|
Control Arm
No (Injection) Intervention
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
138
|
|
Overall Study
COMPLETED
|
121
|
137
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Datscan Product
\[Iodine-123\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \[3-5 millicurie (mCi)\].
|
Control Arm
No (Injection) Intervention
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms
Baseline characteristics by cohort
| Measure |
Datscan Product
n=121 Participants
\[Iodine-123\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \[3-5 millicurie (mCi)\].
|
Control Arm
n=137 Participants
No (Injection) Intervention
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
75 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
|
Age Continuous
|
66.9 years
STANDARD_DEVIATION 12.1 • n=93 Participants
|
65.5 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
66.2 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
119 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
37 participants
n=4 Participants
|
69 participants
n=27 Participants
|
|
Region of Enrollment
France
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=93 Participants
|
14 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Region of Enrollment
Norway
|
8 participants
n=93 Participants
|
8 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=93 Participants
|
11 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
38 participants
n=93 Participants
|
41 participants
n=4 Participants
|
79 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.
Outcome measures
| Measure |
Datscan Product
n=116 Participants
\[Iodine-123\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \[3-5 millicurie (mCi)\].
|
Control Arm
n=128 Participants
No (Injection) Intervention
|
|---|---|---|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Significant changes made
|
58 Number of changes in clinical management
|
40 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Initiation of medication not planned
|
33 Number of changes in clinical management
|
28 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Avoidance/withdrawal of medication planned
|
19 Number of changes in clinical management
|
11 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Performance of diagnostic test not planned
|
6 Number of changes in clinical management
|
6 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Avoidance of diagnostic test planned
|
1 Number of changes in clinical management
|
0 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Arrangement of a referral not planned
|
4 Number of changes in clinical management
|
2 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Cancellation of a referral planned
|
0 Number of changes in clinical management
|
0 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Other Actions
|
16 Number of changes in clinical management
|
6 Number of changes in clinical management
|
SECONDARY outcome
Timeframe: From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.Population: The numbers represent the number of changes in decisions that the Doctor made in the clinical management of the patient with Clinically Uncertain Parkinsonism
The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.
Outcome measures
| Measure |
Datscan Product
n=116 Participants
\[Iodine-123\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \[3-5 millicurie (mCi)\].
|
Control Arm
n=128 Participants
No (Injection) Intervention
|
|---|---|---|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Initiation of Medication not planned
|
35 Number of changes in clinical management
|
22 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Avoidance or withdrawal of medication planned
|
16 Number of changes in clinical management
|
6 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Performance of diagnostic test not planned
|
7 Number of changes in clinical management
|
5 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Avoidance of diagnostic test planned
|
0 Number of changes in clinical management
|
0 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Arrangement of referral not planned
|
3 Number of changes in clinical management
|
1 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Cancellation of referral planned
|
0 Number of changes in clinical management
|
1 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Other Actions
|
15 Number of changes in clinical management
|
9 Number of changes in clinical management
|
|
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
Significant changes made
|
48 Number of changes in clinical management
|
28 Number of changes in clinical management
|
Adverse Events
Datscan Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place