A Phase II/III efficacy and safety study of basimglurant in patients with trigeminal neuralgia
Research type
Research Study
Full title
A Phase II/III, multicentre, 8-week run-in phase followed by a 12- week, prospective, parallel-group, double-blind, randomized withdrawal, placebo-controlled study, with a 52 week open label extension, to evaluate the efficacy and safety of daily 1.5 to 3.5 mg basimglurant in patients with pain associated with trigeminal neuralgia with suboptimal response to their current anti-pain therapy
IRAS ID
1004344
Contact name
Joanna Zakrzewska
Contact email
Sponsor organisation
Noema Pharma
Eudract number
2021-001866-39
Clinicaltrials.gov Identifier
Research summary
This is a Phase II/III, multicentre study, to evaluate the efficacy and safety of basimglurant (also known as NOE-101) in patients with pain associated with trigeminal neuralgia (TN) who are not responding well to their current anti-pain therapy.
NOE-101 is a new drug that is being developed for treating people with TN. NOE-101 has also been used in other research studies like this one to see whether it can treat other conditions such as depression and Fragile X syndrome and was found to be well tolerated.
NOE-101 belongs to a group of drugs known as selective mGLu5 receptor antagonists. The mGLu5 receptor is a type of glutamate receptor. It reduces and controls the signals passing between brain cells and cells in the spinal cord and thus may help in reducing the pain that is experienced in conditions such as TN.
The goal of this study is to assess the safety of NOE-101 and to see how well NOE-101 helps in reducing the number of episodes and/or severity of TN pain and also reducing the need for other medication for TN pain. The study will also try to find out if treatment with NOE-101 has a beneficial impact on the functioning and activities in daily life.
There will be 4 periods in this study. Period 0 is when the study doctor will confirm if you are eligible to take part in this study. In Period 1, all patients will get NOE-101. In Period 2, some patients will get NOE-101 and others will get placebo (like a sugar pill). This will be decided by a computer program in a random manner (=there is an equal chance of getting either NOE-101 or placebo). At the end of the study, patients may choose to continue in the Open Label Extension and will get NOE-101.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0013
Date of REC Opinion
25 Feb 2022
REC opinion
Further Information Favourable Opinion