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This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotonic saline | Placebo Comparator |
| |
| Botulinum toxin A | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A | Drug | Subcutaneously injections are given unilaterally in the face at predefined injection sites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders in botulunim toxin A and placebo group | Responders are participants with a 30 % reduction in mean average daily pain score. | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | The degree of concentration change in inflammatory biomarkers (CGRP, CRP, TNF alpha, IL1, IL2, and IL6) in responders versus non-responders in BTX-A and placebo group. | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Tear fluid CGRP |
| Measure | Description | Time Frame |
|---|---|---|
| Pure paroxysmal pain vs. paroxysms with concomitant pain | Patients with purely paroxysmal pain versus patients with concomitant continuous pain. | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Idiopathic vs. classical trigeminal neuralgia |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Recruiting | Glostrup Municipality | 2600 | Denmark |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Isotonic saline | Other | Subcutaneously injections are given unilaterally in the face at predefined injection sites. |
|
The difference in tear fluid calcitonin gene-related peptide (CGRP) between the symptomatic side and the asymptomatic side. |
| Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| 50 % reduction | The proportion of subjects reaching ≥50% reduction in mean Average Daily Pain (ADP) intensity score | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| 75 % reduction | The proportion of subjects reaching ≥75% reduction in mean ADP | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Prolonged 30 % reduction | The proportion of subjects reaching ≥30% reduction in mean ADP | Week 9 to 12 compared with baseline (week -4 to -1) |
| Change in paroxysms | Change in mean number of daily pain paroxysms n BTX-A group and placebo group | Evaluation period (week 2 to 5) and during weeks 9 to 12 compared with baseline (week -4 to -1) |
| PGI-C | Proportion of subjects with a Patient Global Impression of Change (PGI-C) scale response of "much improved" or "very much improved" in BTX-A and placebo group | Week 5 |
| PENN Facial Pain Scale-Revised (PENN-FPS-R) | Change in the PENN-FPS-R | Baseline to week 5 |
| Patient's guess | Proportion of subjects correctly guessing whether they received BTX-A or placebo | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Dropouts | Proportion of dropouts caused by increased intake of trigeminal neuralgia (TN) medication or use of rescue medication in BTX-A group compared to the placebo group through study completion. | Up to 24 weeks |
| Side effects | Proportion of subjects with side-effects registered in weeks 2 to 5 during treatment with BTX-A compared with placebo through study completion. | Up to 24 weeks |
Patients with idiopathic trigeminal neuralgia versus patients with classical trigeminal neuralgia |
| Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Patients with severe pain | Patients with severe pain (defined as ADP ≥7 ) versus patients with less severe pain (ADP < 7) | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Gender distribution | Male patients versus female patients | Evaluation period (week 2 to 5) compared with baseline (week -4 to -1) |
| Disease duration | Patients with a long duration of TN (≥ 5 years) versus patients with a short duration of TN (< 5 years). | Baseline |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |