BASIMGLURANT for Trigeminal neuralgia

Inclusion criteria

• {"criterion_text":"- Inclusion Criteria (Summary): 1.\tAbility and willingness to provide written informed consent and to comply with the study procedures.\n- 2.\tFluency in the language of the investigator, study staff and the informed consent.\n- 3.\tAge 18-75 years.\n- 4.\tDiagnosis of primary trigeminal neuralgia (TN) as per the ICHD3 criteria confirmed by the study neurologist.\n- 5.\tExperience 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.\n- 6.\tFemale 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

• {"criterion_text":"- Exclusion Criteria (Summary): 1.\tCurrent or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.\n- 10.\tAny investigational drug within 90 days prior to initiation of study drug.\n- 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.\n- 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.\n- 13. Body mass index > 39 kg/m2.\n- 14. Patients with severely impaired hepatic function, ie, Child-Pugh score C.\n- 15. Patients with severe renal impairment, ie, eGFR or creatinine clearance lower than 30 mL/min.\n- 2.\tCurrent or prior history of mania, or psychotic episodes.\n- 3.\tHistory of DSM-5-defined substance dependence and/or substance abuse in the last six months [180 days], except for nicotine.\n- 4.\tPatient not willing to discontinue their current TN analgesic medication.\n- 5.\tUse of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week.\n- 6.\tKnown allergic reaction to the investigational drug or one of its components.\n- 7.\tPatients with secondary TN as per the ICHD3 criteria.\n- Medication history: 8.\tPrevious treatment with basimglurant, except with the prior agreement of the medical monitor.\n- 9.\tTreatment with antipsychotics within six months (180 days) of screening."}

Primary endpoints

• {"endpoint_text":"- Period 1: Run-in: Change in pain as measured by the pain diary (TnED). Incidence and severity of AEs. Laboratory, vital signs and cardiovascular safety will also be evaluated. Changes in psychiatric status as measured by the BPRS. Treatment emergent suicidal ideation and behavior as measured by the S-STS.","definition_or_measurement_approach":"Change in pain measured by the pain diary (TnED); incidence and severity of adverse events; laboratory tests, vital signs and cardiovascular safety assessments; psychiatric status measured by BPRS; treatment-emergent suicidal ideation and behavior measured by S-STS."}
• {"endpoint_text":"- Period 2: Double Blind: Time to Loss of Efficacy for each participant as determined by the IAC.","definition_or_measurement_approach":"Time to Loss of Efficacy as determined by the Independent Assessment Committee (IAC) during the 12-week double-blind randomized withdrawal period."}
• {"endpoint_text":"- Open-Label Extension: Incidence and severity of AEs. Laboratory, vital signs and cardiovascular safety will also be evaluated. Changes in psychiatric status as measured by the BPRS. Treatment emergent suicidal ideation and behavior as measured by the S-STS.","definition_or_measurement_approach":"Incidence and severity of adverse events; laboratory, vital signs and cardiovascular safety evaluations; psychiatric status measured by BPRS; treatment-emergent suicidal ideation and behavior measured by S-STS during the open-label extension."}

Secondary endpoints

• {"endpoint_text":"- Period 1: Run-in: • Proportion of pain free days as measured by TnED. • Number and severity of attacks (paroxysms) as well as duration and severity of continuous pain compared with BL1, as measured by TnED • Changes in pain interference with daily activities compared to BL1, as measured by TnED • Mean change from BL1 to Week 8 in the total patient-rated PENN-FPS-R • PGI-C from BL1 to Week 8 • Patient reported rating of the MSQ. • Changes from BL1 to Week 8 in SDS","definition_or_measurement_approach":"Measures recorded via TnED pain diary (proportion of pain-free days, number/severity/duration of paroxysms and continuous pain, interference with activities); patient-rated PENN-FPS-R change from BL1 to Week 8; PGI-C from BL1 to Week 8; patient MSQ ratings; SDS changes from BL1 to Week 8."}
• {"endpoint_text":"- Period 2: Double Blind: • Proportion of pain free days as measured by TnED in the double-blind randomized withdrawal period until end of double-blind randomized treatment or start of pain rescue medication intake. • Number and severity of attacks (paroxysms) as well as severity and duration of continuous pain, as measured by TnED","definition_or_measurement_approach":"Proportion of pain-free days and paroxysm metrics measured by TnED diary during double-blind randomized withdrawal until end of treatment or start of rescue medication."}
• {"endpoint_text":"- • Changes in pain interference with daily activities compared to BL2, as measured by TnED","definition_or_measurement_approach":"Change in pain interference with activities measured by TnED compared to BL2."}
• {"endpoint_text":"- '• Change at the end of double-blind randomized treatment or start of rescue medication intake during the double-blind randomized withdrawal period in the total patient-rated PENN-FPS-R compared with BL2 • PGI-C at the end of double-blind randomized treatment or start of rescue medication intake during the double-blind randomized withdrawal period • Patient reported rating of the MSQ","definition_or_measurement_approach":"Patient-rated PENN-FPS-R change vs BL2 at end of double-blind/randomized withdrawal or start of rescue medication; PGI-C at same timepoint; patient MSQ ratings."}
• {"endpoint_text":"- '• Incidence and severity of AEs. Laboratory and cardiovascular safety will also be evaluated. Changes in psychiatric status as measured by the BPRS. Treatment emergent suicidal ideation and behavior as measured by the S-STS.","definition_or_measurement_approach":"Safety endpoints including incidence/severity of AEs, laboratory and cardiovascular assessments, psychiatric status by BPRS, suicidal ideation/behavior by S-STS."}
• {"endpoint_text":"- 'Open-Label Extension: • Proportion of pain free days as measured by TnED. • Number and severity of attacks (paroxysms) as well as severity and duration of continuous pain, as measured by TnED. • Pain interference with daily activities, as measured by TnED. • Mean scores in the total patient-rated PENN-FPSR. • Overall patient global impression measured by the PGI-S.","definition_or_measurement_approach":"During OLE: TnED-measured proportion of pain-free days, paroxysm metrics, pain interference; mean patient-rated PENN-FPS-R scores; overall patient global impression by PGI-S."}

Denmark

Latest Decision Or Authorization Date

23-10-2024

Number Of Sites

1

Number Of Participants

13

Germany

Latest Decision Or Authorization Date

18-10-2024

Number Of Sites

1

Number Of Participants

12

Spain

Latest Decision Or Authorization Date

18-10-2024

Number Of Sites

4

Number Of Participants

2

Italy

Latest Decision Or Authorization Date

28-10-2024

Number Of Sites

5

Number Of Participants

14

Poland

Latest Decision Or Authorization Date

08-11-2024

Number Of Sites

5

Number Of Participants

70

Primary sponsor

Full Name

Noema Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

PPD Development LP

Responsibilities

codes: 1,12,13,15 (Site contract and negotiations),2,3,5,6,7,8,9

Third parties

• {"country":"United States","full_name":"Marken LLP","duties_or_roles":"IP home-delivery","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG Provider","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"Replior AB","duties_or_roles":"Electronic Patient Reported Outcome","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Colpitts","duties_or_roles":"Subject Transportation","organisation_type":"Health care"}
• {"country":"France","full_name":"Stragen Services S.A.S.","duties_or_roles":"8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 1,12,13,15 (Site contract and negotiations),2,3,5,6,7,8,9","organisation_type":"Pharmaceutical company"}