iNDiGO
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO)
IRAS ID
233988
Contact name
Ray Chaudhuri
Contact email
Sponsor organisation
NeuroDerm Ltd.
Eudract number
2016-002033-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 26 days
Research summary
This research study is of an experimental drug called ND0612, a solution of levodopa/carbidopa (LD/CD) delivered as a continuous subcutaneous (just under the skin) infusion via a pump system to treat your advanced Parkinson’s disease.
This study is based on the assumption that treatment with ND0612 will enable the administration of levodopa in a more continuous manner compared to current levodopa oral products thereby leading to more stable levodopa plasma levels, and a corresponding reduction in motor fluctuations.
ND0612 is a combination product that will be administered in this clinical study using an infusion pump. As the pump is small, about the same size as a mobile phone, participants will be able to move freely and be unrestricted.
This study will be conducted at between 50 and 80 sites around the world, and will involve 240 participants.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1693
Date of REC Opinion
27 Nov 2017
REC opinion
Further Information Favourable Opinion