An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
- Registration Number
- NCT05217628
- Lead Sponsor
- Noema Pharma AG
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Placebo Placebo - Period 2 (Double blind: Week 9 to Week 20): Participant randomized to placebo will receive the corresponding number of matching placebo capsules. Arm A: Basimglurant/NOE-101 Basimglurant * Period 1 (Run-in: Baseline1 to Week 8): Basimglurant once daily dosing starting dose 1.5mg * Period 2 (Double blind: Weeks 9 to 20): Participants will receive double-blind treatment with Basimglurant once daily. * Open-label Extension (OLE): On completion of Period 2, participants will be offered open label treatment with Basimglurant in an open label extension for up to 52 weeks.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Period 2: Mean change in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale compared with Period 2 baseline (BL2). 12 weeks Impact on facial pain.
Open Label Extension: Severity of attacks (paroxysms). 52 weeks Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Severity of continuous pain. 12 weeks Impact on facial pain measured by patient rated scale via Penn-FPS-R
Open Label Extension: Severity and duration of continuous pain reported in patient pain diary. 52 weeks Evaluate the continued efficacy of basimglurant on facial pain.
Period 2: Frequency of attacks (paroxysms). 12 weeks Impact on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Change in Medication Satisfaction Questionnaire (MSQ). 12 weeks Impact on facial pain.
Open Label Extension: Frequency of attacks (paroxysms). 52 weeks Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Open Label Extension: Measure Global Impression of Severity as captured by PGI-S. 52 weeks Evaluate the continued efficacy of basimglurant on facial pain.
Period 2: Severity of attacks (paroxysms). 12 weeks Impact on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Duration of continuous pain. 12 weeks Impact on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Change in Patient Global Impression of Change (P-GIC). 12 weeks Impact on facial pain.
Trial Locations
- Locations (37)
Hospital Universitario Fundacion Jimenez Diaz (Site #: 1903)
🇪🇸Madrid, Spain
Hospital Universitario La Paz - PPDS (Site #: 1907)
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS (Site #: 1904)
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valencia (Site #: 1906)
🇪🇸Valencia, Spain
Selcuk University Medical Faculty (Site #: 9006)
🇹🇷Selçuklu, Konya, Turkey
Centrum Medyczne Linden (Site #: 2605)
🇵🇱Kraków, Poland
Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz (Site #: 2604)
🇵🇱Lublin, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak (Site #: 2601)
🇵🇱Wrocław, Poland
FutureMeds - Lodzi - PPDS (Site #: 2606)
🇵🇱Łódź, Poland
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, Denmark
Kopfschmerzzentrum Frankfurt (Site #: 1706)
🇩🇪Frankfurt am Main, Hessen, Germany
Universitätsklinikum Essen (Site #: 1702)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitätsklinikum Bonn (Site #: 1707)
🇩🇪Bonn, Germany
St. Ansgar Krankenhaus Höxter -Klinikum Weser Egge (Site #: 1701)
🇩🇪Höxter, Germany
Università Campus Bio Medico Di Roma (Site #: 1805)
🇮🇹Roma, Lazio, Italy
IRCCS San Raffaele Pisana (Site #: 1801)
🇮🇹Roma, Lazio, Italy
La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802)
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera Universitaria Careggi (Site #: 1806)
🇮🇹Florence, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta (Site #: 1804)
🇮🇹Milano, Italy
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Zespo (Site #: 2602)
🇵🇱Dąbrowa Górnicza, Poland
Afyon Kocatepe University Faculty of Medicine (Site #: 9005)
🇹🇷Afyonkarahisar, Turkey
Uludag University Faculty of Medicine Hospital (Site #: 9001)
🇹🇷Bursa, Turkey
Duzce University Health Application and Research Center (9008)
🇹🇷Düzce, Turkey
Istanbul University Istanbul Medical Faculty Hospital (Site #: 9003)
🇹🇷Istanbul, Turkey
Bagcilar Medipol Mega University Hospital (Site #: 9002)
🇹🇷Istanbul, Turkey
Kocaeli University Faculty of Medicine Hospital (Site #: 9004)
🇹🇷Kocaeli, Turkey
Mersin University Faculty of Medicine Hospital (Site #: 9007)
🇹🇷Mersin, Turkey
St Pancras Clinical Research (Site #: 2503)
🇬🇧London, Middlesex, United Kingdom
St. Thomas' Hospital (Site #: 2504)
🇬🇧London, United Kingdom