Trial record 1 of 1 for:
NCT05217628
An Efficacy and Safety Study of Basimglurant in Patients With Trigeminal Neuralgia.
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| ClinicalTrials.gov Identifier: NCT05217628 |
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Recruitment Status :
Recruiting
First Posted : February 1, 2022
Last Update Posted : March 2, 2023
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Sponsor:
Noema Pharma AG
Information provided by (Responsible Party):
Noema Pharma AG
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Trigeminal Neuralgia | Drug: Basimglurant Other: Placebo | Phase 2 Phase 3 |
This study is designed to evaluate the efficacy and safety of basimglurant 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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. |
| Actual Study Start Date : | January 11, 2022 |
| Estimated Primary Completion Date : | April 30, 2024 |
| Estimated Study Completion Date : | August 30, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Trigeminal Neuralgia
| Arm | Intervention/treatment |
|---|---|
Experimental: Arm A: Basimglurant
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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. |
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Placebo Comparator: Arm B: Placebo
- Period 2 (Double blind: Week 9 to Week 20): Participant randomized to placebo will receive the corresponding number of matching placebo capsules.
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Other: Placebo
Participant randomized to receive matching placebo once daily. |
Primary Outcome Measures :
- Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events. [ Time Frame: 8 weeks ]To evaluate the safety of basimglurant daily dosing
- 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. [ Time Frame: 12 weeks ]To assess the maintenance of effect on pain.
- Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events. [ Time Frame: 52 weeks ]To evaluate the long-term safety of basimglurant daily dosing.
Secondary Outcome Measures :
- Period 2: Mean change in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale compared with Period 2 baseline (BL2). [ Time Frame: 12 weeks ]Impact on facial pain.
- Period 2: Frequency of attacks (paroxysms). [ Time Frame: 12 weeks ]Impact on facial pain measured by patient rated scale via Penn-FPS-R
- Period 2: Severity of attacks (paroxysms). [ Time Frame: 12 weeks ]Impact on facial pain measured by patient rated scale via Penn-FPS-R
- Period 2: Severity of continuous pain. [ Time Frame: 12 weeks ]Impact on facial pain measured by patient rated scale via Penn-FPS-R
- Period 2: Duration of continuous pain. [ Time Frame: 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). [ Time Frame: 12 weeks ]Impact on facial pain.
- Period 2: Change in Medication Satisfaction Questionnaire (MSQ). [ Time Frame: 12 weeks ]Impact on facial pain.
- Open Label Extension: Frequency of attacks (paroxysms). [ Time Frame: 52 weeks ]Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
- Open Label Extension: Severity of attacks (paroxysms). [ Time Frame: 52 weeks ]Evaluate the continued efficacy of basimglurant 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. [ Time Frame: 52 weeks ]Evaluate the continued efficacy of basimglurant on facial pain.
- Open Label Extension: Measure Global Impression of Severity as captured by PGI-S. [ Time Frame: 52 weeks ]Evaluate the continued efficacy of basimglurant on facial pain.
Other Outcome Measures:
- Period 1: Mean change from Period 1 baseline (BL1) to Week 8 in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale. [ Time Frame: 8 weeks ]
Evaluate 8-week once daily basimglurant on pain associated with TN on the following:
- Impact on Facial Pain
- Patient perceived change of the pain
- Pain assessments
- Pain freedom
- Patient medication satisfaction
- Period 1: Measure Global Impression of change from Period 1 baseline (BL1) to Week 8. [ Time Frame: 8 weeks ]
Evaluate 8-week once daily basimglurant on pain associated with TN on the following:
- Impact on Facial Pain
- Patient perceived change of the pain
- Pain assessments
- Pain freedom
- Patient medication satisfaction
- Period 1: Number and severity of attacks (paroxysms). [ Time Frame: 8 weeks ]
Evaluate 8-week once daily basimglurant on pain associated with TN on the following:
- Impact on Facial Pain
- Patient perceived change of the pain
- Pain assessments
- Pain freedom
- Patient medication satisfaction
- Period 1: Duration of continuous pain compared with BL1. [ Time Frame: 8 weeks ]
Evaluate 8-week once daily basimglurant on pain associated with TN on the following as measured by patient rated scale via Penn-FPS-R:
- Impact on Facial Pain
- Patient perceived change of the pain
- Pain assessments
- Pain freedom
- Patient medication satisfaction
- Period 1: Severity of continuous pain compared with BL1. [ Time Frame: 8 weeks ]
Evaluate 8-week once daily basimglurant on pain associated with TN on the following as measured by patient rated scale via Penn-FPS-R:
- Impact on Facial Pain
- Patient perceived change of the pain
- Pain assessments
- Pain freedom
- Patient medication satisfaction
- Period 1: Number of pain free days. [ Time Frame: 8 weeks ]
Evaluate 8-week once daily basimglurant on pain associated with TN on the following:
- Impact on Facial Pain
- Patient perceived change of the pain
- Pain assessments
- Pain freedom
- Patient medication satisfaction
- Period 1: Patient reported rating of the Medication Satisfaction Questionnaire (MSQ). [ Time Frame: 8 weeks ]
Evaluate 8-week once daily basimglurant on pain associated with TN on the following:
- Impact on Facial Pain
- Patient perceived change of the pain
- Pain assessments
- Pain freedom
- Patient medication satisfaction
- Period 2: The impact of pain on general activities of daily living captured in patient diary cards. [ Time Frame: 12 weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria (Summary):
- Ability and willingness to provide written informed consent and to comply with the study procedures.
- Fluency in the language of the investigator, study staff and the informed consent.
- Age 18-75 years.
- Diagnosis of primary (classical or idiopathic (with or without paroxysms)) trigeminal neuralgia as per the ICHD3 criteria confirmed by the study neurologist.
- Experience pain defined as at least three paroxysms per day, each rated at an intensity of 4 or more on a pain intensity numerical rating scale (PI-NRS) on at least four days per week. Pain should be present at least 2 months prior to study entry with or without continuous pain.
- Female 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 (Summary):
Patients who meet any of the following criteria will be excluded from participation in this study:
- Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.
- Current or prior history of mania, or psychotic episodes.
- History of DSM-5-defined substance dependence (Diagnostic and Statistical Manual for Mental Disorders, 5th edition) and/or substance abuse in the last six months [180 days], except for nicotine.
- Patient not willing to discontinue their current analgesics. Of note, gabapentin or pregabalin will be discontinued during the first 2 weeks in Period 1 at the latest.
- Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week.
- Known allergic reaction to the investigational drug or one of its components.
- Previous treatment with basimglurant.
- Treatment with antipsychotics within six months (180 days) prior to screening. Treatment of depressive symptoms with selective serotonin reuptake inhibitors is permitted if started more than 6 weeks prior to screening. However, use of low dose antipsychotics for reasons other than psychotic or bipolar disorders e.g., persistent insomnia, is allowed.
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Any investigational drug within 90 days prior to initiation of study drug.
Medical status:
- 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.
- Subject has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.), or has a disease that causes malabsorption.
- Body mass index > 33kg/m²
- Patients with moderate or severe impaired hepatic function, i.e., Pugh-Child score B or C.
- Patients with severe renal impairment, i.e., eGFR or creatinine clearance lower than 30mL/min.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05217628
Contacts
| Contact: Noema Pharma | Please contact via email: | clinicaltrials@noemapharma.com |
Locations
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Sponsors and Collaborators
Noema Pharma AG
| Responsible Party: | Noema Pharma AG |
| ClinicalTrials.gov Identifier: | NCT05217628 |
| Other Study ID Numbers: |
NOE-TGN-201 |
| First Posted: | February 1, 2022 Key Record Dates |
| Last Update Posted: | March 2, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Trigeminal Neuralgia Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations |
Trigeminal Nerve Diseases Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases |