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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01602549

NCT01602549
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Parkinson's disease at a moderate stage (not too early, not the most severe stage), and your movement symptoms are not fully controlled by your current Parkinson's medication (for example, you experience "wearing off" effects, involuntary movements, or delays in the medication working).
  • You have been taking a stable dose of your Parkinson's medication (L-DOPA) for at least four weeks before the screening visit.
  • A breath test shows that your stomach empties food slowly (taking 70 minutes or longer).
  • You are between 40 and 80 years old.
  • You have never had your stomach surgically removed, have not had major stomach surgery, and have had no bowel blockages or narrowings in the past 12 months.
  • Any other medications you take regularly have been at a stable dose for at least four weeks.
  • If you are a woman, you are either past menopause, have had a procedure that means you cannot become pregnant, or you agree to use reliable contraception during the trial and for at least 5 days after the last dose.
  • Your liver function blood test results are within acceptable limits (confirm with trial site).
  • Your heart's electrical activity, measured by an ECG, is within an acceptable range (confirm with trial site).

Who may not be able to join:

  • Your Parkinson's symptoms are very advanced and you experience severe, disabling involuntary movements even on a stable medication dose.
  • You have had, or currently have, a significant uncontrolled mental health condition, serious digestive, blood, hormonal, heart, or nervous system problem (other than Parkinson's), or an active cancer (other than a common type of non-spreading skin cancer) in the past 3 months.
  • You have tested positive for Hepatitis B or Hepatitis C within the past 3 months.
  • You have a gastric pacemaker (a device implanted to help with stomach emptying).
  • You are currently being fed through a tube or drip rather than eating normally.
  • You have severe problems with the part of your nervous system that controls heart rate and blood pressure, for example you have fainted repeatedly in the last 6 months.
  • You have a current or long-term liver condition, or known problems with your liver or bile system (with some exceptions — confirm with trial site).
  • You are pregnant.
  • You are currently breastfeeding.
  • You are unable to avoid drinking red wine, Seville orange juice, or grapefruit juice for 7 days before and during the trial.
  • You have taken certain medications that affect stomach movement or appetite (such as some antibiotics or diabetes medications) within one week before the study.
  • You are unable to avoid certain other prohibited medications in the required timeframe before the study starts (confirm with trial site for the full list).
  • You have taken part in another clinical trial or received an experimental treatment within the past 30 days (or longer, depending on the treatment).
  • You have a known allergy or sensitivity to any of the medications used in this study.
  • Taking part in this trial would mean you donate more than 500 mL of blood within a 56-day period.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
GlaxoSmithKline
Registry
clinicaltrials_gov
Start date
1 July 2012
Est. completion
1 May 2014

Where this trial is recruiting

🇦🇺 Australia 🇩🇪 Germany 🇸🇪 Sweden 🇬🇧 United Kingdom

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline; Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8; Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline; Dose-normalized L-DOPA Cmax at Day 1 and Day 8; L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8; L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov