Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02549092) enrolled 89 people with Parkinson's disease — 44 in a group receiving optimised medical treatment (adjusting existing medicines) and 45 in a group receiving LCIG (levodopa-carbidopa intestinal gel, a medication delivered directly into the small intestine via a tube). The trial ran for 26 weeks and was mainly measuring two things: non-movement symptoms of Parkinson's disease using a questionnaire called the NMSS (which covers things like sleep, mood, memory, and bladder function, scored from 0 to 360, where lower is better), and sleep problems using a questionnaire called the PDSS-2 (scored from 0 to 60, where lower is better). By the end of the treatment period, 41 people in the medical treatment group and 38 in the LCIG group had completed it. The reported data shows that, for the main NMSS non-movement symptom score, both groups had lower (improved) scores at 26 weeks compared to the start — the optimised medical treatment group's score changed by an average of −23.83 points, and the LCIG group's score changed by an average of −32.04 points. For the sleep questionnaire (PDSS-2), the optimised medical treatment group's score changed by −8.98 points on average and the LCIG group's by −7.41 points on average. For a clinician's overall impression of change (rated 1–7, where 1 means "very much improved" and 4 means "no change"), the reported average score was 4.9 for the optimised medical treatment group and 2.5 for the LCIG group. For a quality-of-life questionnaire (PDQ-8, scored 0–100, lower is better), average score changes were −1.75 and −5.56 respectively. A measure of how well participants could manage daily activities (part of a standard Parkinson's rating scale) changed by +0.53 in the medical treatment group and −2.26 in the LCIG group. Several individual sub-scores for specific non-movement symptom areas were also reported, with both groups showing varying degrees of change across categories such as mood, sleep, and gastrointestinal symptoms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Sleep Disorders Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must have been diagnosed with idiopathic Parkinson's disease (the most common form of Parkinson's, not caused by another condition) using a specific set of medical guidelines called the UK Parkinson's Disease Society Brain Bank Criteria.
- You still have ongoing movement problems (such as periods where your medication wears off) even though your treatment has already been adjusted to work as well as possible for you.
- Your Parkinson's symptoms improve when you take levodopa (a common Parkinson's medication).
- You have already tried the best available Parkinson's medications, but your movement symptoms are still not well enough controlled, in your doctor's opinion.
- You must be at least 30 years old (male or female).
- You must have a significant level of sleep problems related to Parkinson's, measured by a specific sleep questionnaire scoring 18 or more out of a possible total (confirm with trial site).
Who may not be able to join:
- Your Parkinson's diagnosis is uncertain, or there is a possibility that you have a different type of movement disorder or a Parkinson's-like condition caused by something else, such as medications, a brain injury, or another neurological disease.
- You have previously had brain surgery to treat your Parkinson's disease.
- You have a known allergy or bad reaction to levodopa, carbidopa, or dye used in X-ray imaging.
- You have a medical condition that means you cannot safely take levodopa, such as a specific type of eye pressure problem (narrow angle glaucoma) or a history of a certain type of skin cancer (malignant melanoma).
- In the three months before the screening visit, you have experienced sudden episodes of falling asleep or have shown significant loss of impulse control (such as compulsive gambling or hypersexuality), as judged by the lead doctor on the trial.
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.
Contact this trial
Principal Investigator: AbbVie Inc., AbbVie
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline to Week 26 in the NMSS Total Score; Change From Baseline to Week 26 in the Modified PDSS-2 Total Score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.