Parkinsonian Syndromes
Conditions
Keywords
Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorder, Clinically uncertain Parkinsonian Syndromes
Brief summary
Patients come to their doctor showing possible symptoms of a movement disorder. It is possible that these symptoms may get worse over time. There is more than one disease that can cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. On the other hand the correct treatment for Parkinson´s Disease is different from the correct treatment for Essential Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can affect the way the doctor treats these patients and whether it can affect their quality of life directly.
Interventions
PROCEDUREDaTSCAN SPECT imaging
A single intravenous injection of DaTSCAN with a total activity of 111-185 MBq (volume of 2.5 or 5.0 mL). SPECT scanning to be performed 3 to 6 hours after DaTSCAN injection.
Sponsors
i3 Statprobe
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability. * Onset of clinical manifestations within the last 5 years
Exclusion criteria
* Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy or between Parkinson´s Disease and Multiple System Atrophy * Subjects with an established/certain movement disorder clinical diagnosis * Presence of known causes of tremor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | 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. | 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. |
Countries
France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Datscan Product \[Iodine-123\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \[3-5 millicurie (mCi)\]. | 121 |
| Control Arm No (Injection) Intervention | 137 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Datscan Product | Control Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 157 Participants | 75 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants | 46 Participants | 55 Participants |
| Age Continuous | 66.2 years STANDARD_DEVIATION 11.9 | 66.9 years STANDARD_DEVIATION 12.1 | 65.5 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment Denmark | 4 participants | 2 participants | 2 participants |
| Region of Enrollment France | 4 participants | 2 participants | 2 participants |
| Region of Enrollment Germany | 40 participants | 20 participants | 20 participants |
| Region of Enrollment Italy | 26 participants | 12 participants | 14 participants |
| Region of Enrollment Norway | 16 participants | 8 participants | 8 participants |
| Region of Enrollment Spain | 17 participants | 6 participants | 11 participants |
| Region of Enrollment Switzerland | 3 participants | 1 participants | 2 participants |
| Region of Enrollment United Kingdom | 79 participants | 38 participants | 41 participants |
| Region of Enrollment United States | 69 participants | 32 participants | 37 participants |
| Sex: Female, Male Female | 119 Participants | 56 Participants | 63 Participants |
| Sex: Female, Male Male | 139 Participants | 65 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 122 | 0 / 137 |
| serious Total, serious adverse events | 0 / 122 | 0 / 137 |
Outcome results
Primary
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
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.
Time frame: Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Significant changes made | 40 Number of changes in clinical management |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Initiation of medication not planned | 28 Number of changes in clinical management |
| Control Arm | 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 | 2 Number of changes in clinical management |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Avoidance/withdrawal of medication planned | 11 Number of changes in clinical management |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Other Actions | 6 Number of changes in clinical management |
| Control Arm | 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 |
| Control Arm | 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 |
| Control Arm | 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 |
Secondary
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Datscan Product | 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 |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Significant changes made | 28 Number of changes in clinical management |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Initiation of Medication not planned | 22 Number of changes in clinical management |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Arrangement of referral not planned | 1 Number of changes in clinical management |
| Control Arm | 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 | 6 Number of changes in clinical management |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Other Actions | 9 Number of changes in clinical management |
| Control Arm | 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 | 5 Number of changes in clinical management |
| Control Arm | Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. | Cancellation of referral planned | 1 Number of changes in clinical management |
| Control Arm | 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 |