An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

January 11, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

February 1, 2027

Conditions
Trigeminal Neuralgia
Interventions
DRUG

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."

OTHER

Placebo

Participant randomized to receive matching placebo once daily.

Trial Locations (34)

2100

Danish Headache Center (Site #: 1201), Glostrup Municipality

10032

Columbia University - Irving Medical Center (Site #: 1008), New York

16059

Uludag University Faculty of Medicine Hospital (Site #: 9001), Bursa

20133

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta (Site #: 1804), Milan

28040

Hospital Universitario Fundacion Jimenez Diaz (Site #: 1903), Madrid

28046

Hospital Universitario La Paz - PPDS (Site #: 1907), Madrid

30265

Vista Clinical Research,LLC (Site#: 1010), Newnan

33343

Mersin University Faculty of Medicine Hospital (Site #: 9007), Mersin

33612

University of South Florida (Site #: 1002), Tampa

34093

Istanbul University Istanbul Medical Faculty Hospital (Site #: 9003), Istanbul

34214

Bagcilar Medipol Mega University Hospital (Site #: 9002), Istanbul

41001

Kocaeli University Faculty of Medicine Hospital (Site #: 9004), Kocaeli

41013

Hospital Universitario Virgen del Rocio - PPDS (Site #: 1904), Seville

42075

Selcuk University Medical Faculty (Site #: 9006), Selçuklu

45219

University of Cincinnati (Site #: 1007), Cincinnati

46010

Hospital Clinico Universitario de Valencia (Site #: 1906), Valencia

50134

Azienda Ospedaliera Universitaria Careggi (Site #: 1806), Florence

53127

Universitätsklinikum Bonn (Site #: 1707), Bonn

81620

Duzce University Health Application and Research Center (9008), Düzce

92037

Kaizen Brain Center (Site #: 1001), La Jolla

33142-3911

L & A Morales Healthcare INC (Site#: 1011), Miami

02215

Beth Israel Deaconess Medical Center (Site #: 1004), Boston

89102-1972

Altea Research - Nevada - ClinEdge - PPDS (Site #1006), Las Vegas

00128

Università Campus Bio Medico Di Roma (Site #: 1805), Rome

00163

IRCCS San Raffaele Pisana (Site #: 1801), Rome

00185

La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802), Rome

41-300

Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Zespo (Site #: 2602), Dąbrowa Górnicza

30-721

Centrum Medyczne Linden (Site #: 2605), Krakow

91-363

FutureMeds - Lodzi - PPDS (Site #: 2606), Lodz

20-090

Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz (Site #: 2604), Lublin

52-210

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak (Site #: 2601), Wroclaw

03030

Afyon Kocatepe University Faculty of Medicine (Site #: 9005), Afyonkarahisar

SE1 7EH

St. Thomas' Hospital (Site #: 2504), London

EC2Y 8EA

St Pancras Clinical Research (Site #: 2503), London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Noema Pharma AG

INDUSTRY

NCT05217628 - An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia. | Biotech Hunter | Biotech Hunter