Study on Basimglurant for Treating Pain in Patients with Trigeminal Neuralgia

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What is this study about?

This clinical trial is focused on studying the treatment of Trigeminal Neuralgia, a condition that causes severe facial pain. The study will use a medication called Basimglurant, which is taken in capsule form. The purpose of the study is to evaluate the safety and effectiveness of Basimglurant in reducing pain for patients who have not had sufficient relief from their current pain treatments.

The study will begin with an 8-week period where participants will start taking Basimglurant daily. This is followed by a 12-week phase where participants will continue taking the medication or a placebo, without knowing which one they are receiving. This is to help understand how well the medication works compared to no active treatment. After this, there is a 52-week period where all participants will receive Basimglurant to further assess its long-term safety and effectiveness.

Throughout the study, participants will be monitored for any changes in their pain levels and overall health. The study aims to provide valuable information on how Basimglurant can help manage pain associated with Trigeminal Neuralgia and improve the quality of life for those affected by this condition.

1 run-in phase

During the first 8 weeks, you will begin the run-in phase. This phase is designed to evaluate the safety, tolerability, and effectiveness of the medication basimglurant for managing pain associated with trigeminal neuralgia.

You will take basimglurant orally in capsule form, with a daily dose ranging from 1.5 mg to 3.5 mg. The exact dosage will be determined by the study team.

Throughout this phase, you will be asked to keep a pain diary to record any changes in your pain levels. Regular assessments will be conducted to monitor your health, including laboratory tests, vital signs, and evaluations of your psychiatric status.

2 double-blind phase

Following the run-in phase, you will enter a 12-week double-blind phase. In this phase, neither you nor the study team will know whether you are receiving basimglurant or a placebo.

The purpose of this phase is to assess the maintenance of pain relief with basimglurant compared to a placebo. You will continue to take the medication once daily, with the same dosage range of 1.5 mg to 3.5 mg.

Your pain levels and overall health will be closely monitored, and you will continue to keep a pain diary. The study team will evaluate the time it takes for any loss of pain relief to occur.

3 open-label extension

After completing the double-blind phase, you will have the option to participate in a 52-week open-label extension. In this phase, all participants will receive basimglurant, and both you and the study team will know that you are receiving the active medication.

The goal of this phase is to evaluate the long-term safety of basimglurant when taken daily at doses of 1.5 mg to 3.5 mg.

Your health will continue to be monitored through regular assessments, including laboratory tests and evaluations of your psychiatric status. You will also be asked to report any side effects or changes in your condition.

Who Can Join the Study?

Ability and willingness to provide written informed consent and to follow the study procedures.
Fluency in the language spoken by the investigator and study staff, and in the informed consent document.
Age between 18 and 75 years.
Diagnosis of primary trigeminal neuralgia (TN) confirmed by the study neurologist. TN is a condition that causes sudden, severe facial pain.
Experience pain due to TN, with at least 3 episodes of pain per day, each with an intensity of 4 or more on a pain scale, during the last 7 days.
Female patients must be either sterile or menopausal. If they can have children, they must not be pregnant or breastfeeding and must use appropriate birth control methods, with prior negative pregnancy tests.

Who Cannot Join the Study?

Patients who have any other significant medical conditions that could interfere with the study.
Patients who are currently taking medications that might affect the study results.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that might affect their ability to participate in the study.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Linden Sp. z o.o. sp.k.	Cracow	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland
Galen Clinic	Lublin	Poland

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Irccs San Raffaele Roma S.r.l.	Rome	Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Rigshospitalet	Copenhagen	Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centrum Leczenia MIGRE	Wroclaw	Poland
NZOZ Zespół Medyczno Opiekuńczy Alicja Kluczna	Dabrowa Gornicza	Poland
Uojttbiqwb Dyemh Sqcvd De Rzqt Lv Sigmfkze	Rome	Italy
Fgpgqsase Pyyj Ll Ixhuzofqaadxx Bgcszhjnl Dph Hpfzyfhr Ulhldkfeywnuu Le Pmk	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.12.2021
Germany	Not recruiting	01.12.2021
Italy	Not recruiting	01.12.2021
Poland	Not recruiting	01.12.2021
Spain	Not recruiting	01.12.2021

Trial locations

Investigated drugs:

Basimglurant

Basimglurant is a medication being studied for its potential to help people with trigeminal neuralgia, a condition that causes severe facial pain. In this clinical trial, researchers are testing how well basimglurant can reduce pain when taken daily. They are also looking at how safe it is for long-term use. The trial includes different phases to see if the medication can maintain its pain-relieving effects over time. Participants will take basimglurant to see if it helps with their pain when other treatments have not worked well enough.

Investigated diseases:

Trigeminal neuralgia

Trigeminal neuralgia – Trigeminal neuralgia is a chronic pain condition that affects the trigeminal nerve, which carries sensation from the face to the brain. It is characterized by sudden, severe, and stabbing pain, often described as an electric shock, typically on one side of the face. The pain episodes can last from a few seconds to several minutes and may occur in quick succession. Over time, the frequency and intensity of the pain can increase, and the intervals between attacks may shorten. The condition can be triggered by routine activities such as eating, talking, or even touching the face. As the disease progresses, the pain may become more constant and less responsive to typical triggers.

Trial ID:

2024-514497-41-00

Protocol code:

NOE-TGN-201

NCT ID:

NCT05217628

Trial Phase:

Therapeutic use (Phase IV)

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Study on Basimglurant for Treating Pain in Patients with Trigeminal Neuralgia

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