Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

Trial Profile

Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2018

At a glance

  • Drugs Levodopa/carbidopa (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions
  • Sponsors Abbott Laboratories; AbbVie
  • Most Recent Events

    • 23 Mar 2018 Study protocol was amended in Dec 2013 to include efficacy assessments that had been used in the qualifying studies for patients at US sites: the PD symptom diary, Unified Parkinsons Disease Rating Scale, and the Parkinsons Disease Questionnaire-39, according to results published in the Movement Disorders Journal.
    • 23 Mar 2018 Study protocol was amended in Jul 2011 to include laboratory tests to evaluate selective B vitamin deficiencies, according to results published in the Movement Disorders Journal.
    • 23 Mar 2018 Results assessing long-term safety and efficacy outcomes (data cutoff date: 30 Sep 2015), published in the Movement Disorders Journal.
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