ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II/III, Multicentre, 8-week run-in Phase Followed by a 12-week, Prospective, Parallel-group, Double-blind, Randomized Withdrawal, Placebo-controlled Study, With a 52 Week Open Label Extension, to Evaluate the Efficacy and Safety of Daily 1.5 to 3.5 mg Basimglurant in Patients With Pain Associated With Trigeminal Neuralgia With Suboptimal Response to Their Current Anti-pain Therapy.

Quick Facts

Study Start:2022-01-11
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05217628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Kaizen Brain Center (Site #: 1001)
La Jolla, California, 92037
United States
L & A Morales Healthcare INC (Site#: 1011)
Miami, Florida, 33142-3911
United States
University of South Florida (Site #: 1002)
Tampa, Florida, 33612
United States
Vista Clinical Research,LLC (Site#: 1010)
Newnan, Georgia, 30265
United States
Beth Israel Deaconess Medical Center (Site #: 1004)
Boston, Massachusetts, 02215
United States
Altea Research - Nevada - ClinEdge - PPDS (Site #1006)
Las Vegas, Nevada, 89102-1972
United States
Columbia University - Irving Medical Center (Site #: 1008)
New York, New York, 10032
United States
University of Cincinnati (Site #: 1007)
Cincinnati, Ohio, 45219
United States

Collaborators and Investigators

Sponsor: Noema Pharma AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-11
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2022-01-11
Study Completion Date2027-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Trigeminal Neuralgia