Basimglurant: 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.
Placebo: Participant randomized to receive matching placebo once daily.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria (Summary):
1. Ability and willingness to provide written informed consent and to comply with the study procedures.
2. Fluency in the language of the investigator, study staff and the informed consent.
3. Age 18-75 years.
4. Diagnosis of primary trigeminal neuralgia (TN) as per the ICHD-3 criteria confirmed by the study neurologist.
5. Experience pain due to TN and at baseline, experience at least 3 paroxysms per day of at least intensity of 4 or more on a pain intensity numerical rating scale (PI-NRS) during the last 7 days.
6. Female patients who are either sterile or menopausal. For female patients with childbearing potential, must be neither pregnant nor lactating (with appropriate contraceptive precautions and prior negative pregnancy tests).
Exclusion Criteria (Summary):
Patients who meet any of the following criteria will be excluded from participation in this study:
1. Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.
2. Current or prior history of mania, or psychotic episodes.
3. History of DSM-5-defined substance dependence and/or substance abuse in the last six months \[180 days\], except for nicotine.
4. Patient not willing to discontinue their current TN analgesic medication.
5. Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week.
6. Known allergic reaction to the investigational drug or one of its components.
7. Patients with secondary TN as per the ICHD-3 criteria.
Medication history:
8. Previous treatment with basimglurant, except with the prior agreement of the medical monitor.
9. Treatment with antipsychotics within six months (180 days) of screening.
10. Any investigational drug within 90 days prior to initiation of study drug.
Medical status:
11. Evidence of clinically significant, uncontrolled, unstable medical conditions or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
12. Subject has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.) that may, in the opinion of the investigator, may cause malabsorption, or has a disease of the GI tract that causes malabsorption.
13. Body mass index \> 39kg/m²
14. Patients with moderate or severely impaired hepatic function, ie, Pugh-Child score C.
15. Patients with severe renal impairment, ie, eGFR or creatinine clearance lower than 30mL/min.
Primary outcome measure(s)
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events. — 8 weeks Change in pain as measured by the pain diary (TnED).
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. — 12 weeks To assess the maintenance of effect on pain.
Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events. — 52 weeks To evaluate the long-term safety of basimglurant daily dosing.
Trial sites (34)
Facility
City
Region
Status
Kaizen Brain Center (Site #: 1001)
La Jolla
California
L & A Morales Healthcare INC (Site#: 1011)
Miami
Florida
University of South Florida (Site #: 1002)
Tampa
Florida
Vista Clinical Research,LLC (Site#: 1010)
Newnan
Georgia
Beth Israel Deaconess Medical Center (Site #: 1004)
Boston
Massachusetts
Altea Research - Nevada - ClinEdge - PPDS (Site #1006)
Las Vegas
Nevada
Columbia University - Irving Medical Center (Site #: 1008)
New York
New York
University of Cincinnati (Site #: 1007)
Cincinnati
Ohio
Danish Headache Center (Site #: 1201)
Glostrup Municipality
Denmark
Universitätsklinikum Bonn (Site #: 1707)
Bonn
Germany
Università Campus Bio Medico Di Roma (Site #: 1805)
Rome
Lazio
IRCCS San Raffaele Pisana (Site #: 1801)
Rome
Lazio
La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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