Clinical Efficacy & Safety of AP CD/LD in Fluctuating PD
Research type
Research Study
Full title
A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients
IRAS ID
192524
Contact name
Simon Ellis
Contact email
Sponsor organisation
Intec Pharma, Ltd.
Eudract number
2015-003512-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 10 days
Research summary
Parkinson’s disease (PD) is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson’s disease result from the death of Dopamine secreting cells in the brain. Cells are building blocks of the body and each cell has certain functions. Some cells release substances (e.g. Dopamine) that help communication between brain cells.
Parkinson’s disease (PD) affects about 1% of the population over the age of 55 years. An estimated 5 million people throughout the world have PD, with one million individuals, each, in the United States and in Europe with the disorder. As the population ages, there are more at-risk individuals older than 55 years; therefore the prevalence of PD is expected to increase substantially in the coming decades.
The medical management goal is to provide control of PD signs and symptoms for as long as possible while minimising side effects. The gold standard treatment is dopamine replacement therapy with the dopamine precursor Levodopa (L-dopa or LD), which can permeate via the blood brain barrier to some tissues.
The purpose of this study is to assess the safety, tolerability and effectiveness of Accordion Pill Carbidopa/Levodopa (AP-CD/LD) compared to Immediate Release Carbidopa/Levodopa (IR CD/LD) (Sinemet®)in fluctuating PD patients.
Approximately 460 PD patients, 35 to 85 years old, inclusive, will be enrolled into the study, with approximately 440 participants equally randomised to treatment with (AP-CD/LD) or with (IR CD/LD).
The study will have 2 open label periods of 6 weeks each prior to the double blind period. In the open label periods all participants will be stabilised on the active comparator Sinemet® and on AP-CD/LD. The double blind active period will be 13 weeks long.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0081
Date of REC Opinion
28 Apr 2016
REC opinion
Further Information Favourable Opinion