Trigeminal neuralgia (TN), also called "tic douloureux", is the most common form of craniofacial neuropathic pain and is considered the cause of one of the most painful afflictions known in medical practice. This study is designed to evaluate the efficacy and safety of 1.5mg - 3.5mg basimglurant in adults with TN.
This study is designed to evaluate the efficacy and safety of basimglurant (NOE-101) in patients with TN. Basimglurant is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5) which controls a wide range of processes in both central and peripheral nervous system. Inhibition of the mGluR5 receptor has shown therapeutic potential for pain associated with conditions such as TN. The drug has been shown to have a favorable safety profile in adults, children and adolescents. The aim of the study is to determine whether Basimglurant decreases both duration and intensity of facial pain associated with TN by use of a patient pain diary and the Patient-reported Global Impression of Change (PGI-C) compared to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
Period 1: Basimglurant 1.5 to 3.5 mg QD titrated on individual tolerability. Period 2: Patients randomized to receive either double blind Basimglurant at the tolerated dose from Period 1 or Placebo. OLE: Open label Basimglurant at the dose tolerated from Period 2, patients previously assigned placebo in period to be titrated to the Period 1.
Participant randomized to receive matching placebo once daily.
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
Change in pain as measured by the pain diary (TnED).
Time frame: 8 weeks
Period 2: Time to Loss of Efficacy or pain recurrence defined as the confirmed increase in the number of weekly paroxysms or re-emergence of continuous pain and/or the need for rescue medication.
To assess the maintenance of effect on pain.
Time frame: 12 weeks
Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
To evaluate the long-term safety of basimglurant daily dosing.
Time frame: 52 weeks
Period 2: Mean change in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale compared with Period 2 baseline (BL2).
Impact on facial pain.
Time frame: 12 weeks
Period 2: Frequency of attacks (paroxysms).
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Time frame: 12 weeks
Period 2: Severity of attacks (paroxysms).
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Time frame: 12 weeks
Period 2: Severity of continuous pain.
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Time frame: 12 weeks
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Kaizen Brain Center (Site #: 1001)
La Jolla, California, United States
L & A Morales Healthcare INC (Site#: 1011)
Miami, Florida, United States
University of South Florida (Site #: 1002)
Tampa, Florida, United States
Vista Clinical Research,LLC (Site#: 1010)
Newnan, Georgia, United States
Beth Israel Deaconess Medical Center (Site #: 1004)
Boston, Massachusetts, United States
Altea Research - Nevada - ClinEdge - PPDS (Site #1006)
Las Vegas, Nevada, United States
Columbia University - Irving Medical Center (Site #: 1008)
New York, New York, United States
University of Cincinnati (Site #: 1007)
Cincinnati, Ohio, United States
Danish Headache Center (Site #: 1201)
Glostrup Municipality, Denmark
Universitätsklinikum Bonn (Site #: 1707)
Bonn, Germany
...and 24 more locations
Period 2: Duration of continuous pain.
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Time frame: 12 weeks
Period 2: Change in Patient Global Impression of Change (P-GIC).
Impact on facial pain.
Time frame: 12 weeks
Period 2: Change in Medication Satisfaction Questionnaire (MSQ).
Impact on facial pain.
Time frame: 12 weeks
Open Label Extension: Frequency of attacks (paroxysms).
Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Time frame: 52 weeks
Open Label Extension: Severity of attacks (paroxysms).
Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Time frame: 52 weeks
Open Label Extension: Severity and duration of continuous pain reported in patient pain diary.
Evaluate the continued efficacy of basimglurant on facial pain.
Time frame: 52 weeks
Open Label Extension: Measure Global Impression of Severity as captured by PGI-S.
Evaluate the continued efficacy of basimglurant on facial pain.
Time frame: 52 weeks