MOT115816 Gastroparesis and Parkinson's disease

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease exhibiting delayed gastric emptying

• IRAS ID

  100025

• Contact name

  David J Burn

• Sponsor organisation

  GSK

• Eudract number

  2011-004438-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by degeneration of nigrostriatal dopaminergic neurones. It affects 1.5% of the global population over 65 years of age. Cardinal symptoms comprise bradykinesia, rigidity, resting tremors and postural instability. Gastrointestinal dysfunction, including gastroparesis, is a frequent feature of PD affecting approximately 90% of patients [Pfeiffer, 2003], and is caused by autonomic dysfunction as well as an adverse effect of antiparkinsonian drug therapy [Jost, 1997]. The therapeutic mainstay for PD treatment is the neutral amino acid L 3,4 dihydroxyphenylalanine (L-DOPA), a dopamine prodrug, as it provides the most rapid and effective symptomatic control of motor impairment in PD [Hoehn, 1992]. The primary determinant of L-DOPA bioavailability is gastric emptying (GE); delays in GE slow delivery of L-DOPA to its proximal small intestinal absorption sites, increasing the extent of presystemic metabolism, and leading to slowed and diminished absorption [Contin, 2010]. GSK962040 is a novel small molecule motilin agonist and is currently in Phase II clinical development for gastroparesis. This is a proof of concept study to investigate the ability of the motilin receptor agonist GSK962040 to improve L-DOPA pharmacokinetics (PK) by enhancing GE. Treatment with a gastric prokinetic may provide dual benefit to the PD patient by improving symptoms of delayed GE, as well as improving the bioavailability of L-DOPA, leading to better symptomatic control of motor function.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  12/NE/0087

• Date of REC Opinion

  25 Apr 2012

• REC opinion

  Further Information Favourable Opinion