Status:
Active, No Longer Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Intec Pharma
Enrollment:
420
Study Design:
The phase 3 Accordance study is a multi-center (97 study locations), global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with fluctuating PD. The study will have 2 open label titration periods of 6 weeks each prior to the double-blind maintenance period. In the open label periods, all patients will be stabilized on the active comparator, IR-CD/LD and then on AP-CD/LD. The double-blind maintenance period will be 13 weeks long.
Rationale:
The primary outcome is change from baseline through to study completion, an average of 27 weeks, in the percentage of daily “Off time” during waking hours, based on Hauser Home Diary assessments. Secondary outcomes, all measured on the same timescale as the primary outcome, are: 1. Change in “On time” without troublesome dyskinesia during waking hours; 2. Change in the number of total daily LD doses; 3. Clinical Global Impression Improvement (CGI-I), as recorded by physician & patient; 4. Change in total UPDRS Score (sum of Parts I-III).
Comments:
Until disease-modifying therapies are available, people with Parkinson’s will welcome any therapy that extends the duration of symptom relief and reduces motor fluctuations. The novel design of the Accordion Pill and the promising safety and efficacy data generated in phases 1 and 2, hold out great hope for the achievement of these benefits.
