Summary of studies included in pooled analysis
| Principal study | ||||
|---|---|---|---|---|
| DP008-003 | PDT304 | PDT301 | PDT408 | |
| Study design | ▸ Phase 3 ▸ Multicentre, open-label, non-randomised ▸ Single-dose ▸ Expert clinical diagnosis at baseline according to published consensus criteria as the RCD | ▸ Phase 3 ▸ Multicentre, open-label, non-randomised ▸ Repeat-dose (maximum of 3) ▸ Expert clinical diagnosis at 36 months as the RCD | ▸ Phase 3 ▸ Multicentre, open-label, non-randomised ▸ Single-dose ▸ Expert clinical diagnosis at 12 months as the RCD | ▸ Phase 4 ▸ Multicentre, open-label, non-randomised ▸ Single-dose ▸ Expert clinical diagnosis at 24 months as the RCD |
| Dates study was conducted | ▸ August 1997 to February 1998 | ▸ January 1999 to June 2005 | ▸ December 2003 to June 2006 | ▸ November 2000 to November 2003 |
| Population | ▸ Healthy volunteers ▸ Participants with a clinical diagnosis of: ▸ Parkinson's disease ▸ Multiple system atrophy ▸ Progressive supranuclear palsy or ▸ Essential tremor | ▸ Healthy volunteers ▸ Participants with the clinical features of: ▸ Early Parkinson's disease or ▸ Tremor (mainly essential tremor) | ▸ Participants with dementia (features of possible DLB or with features of other dementia (AD, VaD)) | ▸ Participants with movement disorders (an uncertain clinical diagnosis as to PS or non-PS) |
| Efficacy objectives | ▸ Primary ▸ Sensitivity and specificity for detecting or excluding an SDDD ▸ Secondary ▸ Inter-reader agreement | ▸ Primary ▸ Sensitivity and specificity for detecting or excluding an SDDD ▸ Secondary ▸ Inter-reader agreement | ▸ Primary ▸ Sensitivity and specificity for detecting or excluding an SDDD ▸ Secondary ▸ Inter-reader agreement | ▸ Primary* ▸ Impact of ioflupane (123I) image assessments on patient diagnoses, confidence that patient had PS, and planned management ▸ Secondary ▸ Sensitivity and specificity for detecting or excluding an SDDD |
| Type of control | No control used | No control used | No control used | No control used |
| Investigational product | Ioflupane (123I) 111–185 MBq (3–5 mCi) iv, 1 dose | Ioflupane (123I) 111–185 MBq (3–5 mCi) iv, 3 doses 18 months apart | Ioflupane (123I) 111–185 MBq (3–5 mCi) iv, 1 dose | Ioflupane (123I) 111–185 MBq (3–5 mCi) iv, 1 dose (73 participants) or 2 doses 24 months apart (14 participants) |
| Number of study centres | 6 | 10 | 40 | 15 |
| Number of participants enrolled | 250 | 202 | 351 | 125 |
| Age of ITD population, range (mean) | 40, 80 (62.7) | 33, 79 (60.4) | 54, 90 (73.9) | 25, 84 (64.2) |
| Gender | 62% male, 38% female | 56% male, 44% female | 57% male, 43% female | 58% male, 42% female |
| Race | Caucasian 98% Black 1% Asian <1% | Caucasian 100% | Caucasian 100% | Caucasian 99% Asian 1% |
| Number of participants evaluable for efficacy | 220 | 102 | 288 | 118 |
| Blinded reads performed | Yes | Yes | Yes | No |
*Primary objective was to assess clinical utility of ioflupane (123I) images; however, images were used for pooled efficacy analysis.
AD, Alzheimer's disease; DLB, dementia with Lewy bodies; ITD, intent to diagnose; MBq, megabecquerel; PS, parkinsonian syndrome; RCD, reference clinical diagnosis; SDDD, striatal dopaminergic deficit disorder; VaD, vascular dementia.