OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004
Research type
Research Study
Full title
An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
IRAS ID
192525
Contact name
Simon Ellis
Contact email
Sponsor organisation
Intec Pharma, Ltd.
Eudract number
2015-003513-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 7 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 open-label extension research study is to assess the long-term safety, tolerability and effectiveness of Accordion Pill Carbidopa/Levodopa (AP-CD/LD) in patients with fluctuating Parkinson’s disease (PD) who completed the main study (IN 11 004). These will be assessed by looking at how AP-CD/LD affects the symptoms of Parkinson’s disease long-term by evaluating the responses that the participants provide on questionnaires, rating scales and examinations. This study will also allow participants to benefit from extended treatment with AP-CD/LD after they have successfully completed the main study IN 11 004.
Approximately 460 participants from Europe and from the US will participate in this research study. Participation in this study could last up to 12 months.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0082
Date of REC Opinion
28 Apr 2016
REC opinion
Further Information Favourable Opinion