Apomorphine Subcutaneous Injection for the management of Morning Akinesia in Parkinson's Disease (AM IMPAKT study)

AM IMPAKT is a Phase IV, multi-centre, open-label study investigating treatment with APO-go® PEN to achieve rapid and reliable improvement of motor symptoms in Parkinson’s disease patients who experience delayed onset of their oral levodopa medication taken upon awakening (Early Morning OFF). Twelve centres in the US participated in the study. The total number of patients enrolled was 88. (Safety population = 127). Please click on the following link to access the online publication – Isaacson S, et al. Apomorphine Subcutaneous Injection for the Management of Morning Akinesia in Parkinson’s Disease. Move Disord. 2016. Published online at DOI: 10.1002/mcd3.12350.

Early morning ‘OFF’ is prevalent in patients with Parkinson’s

Parkinson’s patients at all stages of their disease can experience Early Morning OFFs, which can go undiagnosed for years, despite receiving treatment for their motor symptoms.5

Patients included in the AM IMPAKT study had been diagnosed with Parkinson’s for between 5.5–17.5 years and had, on average, been experiencing early morning ‘OFFs’ for 4.5 years.5

APO-go® PEN achieves significantly faster Time-To-‘ON’ than oral levodopa therapy

Patients with early morning ‘OFF’ periods due to delayed onset of oral L-dopa had a rapid turning ‘ON’ after receiving APO-go® PEN. The mean ± SD time-to-ON reduced from 60.86 ±18.11 minutes at baseline with L-dopa therapy to 23.72 ± 14.55 minutes at the end of the treatment period (reduction of 37.14 ± 20.51 minutes; P < 0.0001 vs. baseline).5

Time-To-‘ON’ during the L-dopa baseline period and apomorphine treatment period5

APO-go® PEN was significantly more reliable than oral levodopa therapy at resolving early morning ‘OFFs’

A dose failure in AM IMPAKT was defined as Time-To-‘ON’ >60 minutes and was reported for 144 of 310 (46%) of completed diary entries during the L-dopa baseline week. Whereas, APO-go® PEN only had 20 of 307 (7%) dose failures reported.

Dose failures during the L-dopa baseline period and apomorphine treatment period5

Time-to-‘ON’ was highly reliable in the APO-go® PEN treatment phase – 95.5% of patients (84 of 88) had improvement in Time-To-‘ON’5

Patients treated with APO-go® PEN vs. oral levodopa feel more benefit from their Early Morning OFF treatment5

Compared with investigators, patients consistently rated their baseline disease severity as worse suggesting patients find morning akinesia a more significant problem than is currently recognised in clinical practice. Patients also consistently rated their degree of improvement in disease severity as greater with apomorphine suggesting that patients treated with APO-go® PEN versus oral levodopa feel more benefit from their early morning off treatment.

Key safety data

Data from AM IMPAKT demonstrate the tolerability and consistency of adverse events associated with APO-go®. No new safety issues with apomorphine were observed during the study.5

Adverse events occurring in ≥5% of the safety population were:5

  • Nausea (26.8%)
  • Dizziness (16.5%)
  • Yawning (10.2%)
  • Somnolence (7.9%)
  • Hypotension (7.9%)
  • Vomiting (7.1%)

Eleven adverse events of severe intensity were reported in 6 subjects.5

Nausea, vomiting, and hypotension were also the most common AEs leading to discontinuation. A total of 23 (18%) of patients discontinued APO-go® PEN therapy.5

Click the button below for full safety information on APO-go®, or see the summary of product characteristics available at the foot of each page.

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AM IMPAKT Study interim results. Presented at International Parkinson and Movement Disorder Society. Treatment of Parkinson’s Disease: Past, Present and Future. March 2014, Miami, Florida, USA.
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