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Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
trial testing Vagus Nerve Stimulation Therapy in Epilepsy in 67 participants. Completed in 10 October 2016.
| Lead sponsor | Cyberonics, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 67 |
| Start date | 28 April 2015 |
| Primary completion | 10 October 2016 |
| Estimated completion | 10 October 2016 |
| Sites | 15 locations across United States |
Cyberonics, Inc. — full company profile →
12 and older, any sex, with Epilepsy or Seizures. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame
| Group | Value | 95% CI |
|---|---|---|
| Group A | 18 | |
| Group B | 9 | |
| Group C | 12 |
Time frame: Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group A | Group B | Group C |
|---|---|---|---|---|
| Peripheral arterial occlusive disease | Vascular disorders | — | — | — |
| Reaction | System | Group A | Group B | Group C |
|---|---|---|---|---|
| Diarrhoea [U] | Gastrointestinal disorders | — | — | — |
| Incision site pain [I] | Injury, poisoning and procedural complications | — | — | — |
| Urinary tract infection [U] | Infections and infestations | — | — | — |
| Neck pain [I] | Musculoskeletal and connective tissue disorders | — | — | — |
| Somnolence [U] | Nervous system disorders | — | — | — |
| Cough [S] | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Oropharyngeal pain [I] [S] | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Throat tightness [S] | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Palpatations [S] | Cardiac disorders | — | — | — |
| Cerumen impaction [U] | Ear and labyrinth disorders | — | — | — |
| Tinnitus [U] | Ear and labyrinth disorders | — | — | — |
| Constipation [U] | Gastrointestinal disorders | — | — | — |
| Dysphagia [S] | Gastrointestinal disorders | — | — | — |
| Chest Pain [S] | General disorders | — | — | — |
| Discomfort [S] | General disorders | — | — | — |
| Fatigue [S] | General disorders | — | — | — |
| Implant site hoematoma [I] | General disorders | — | — | — |
| Medical device discomfort [S] | General disorders | — | — | — |
| Medical device pain [S] [SI] | General disorders | — | — | — |
| Non-cardiac chest pain [S] | General disorders | — | — | — |
| Cellulitis [U] | Infections and infestations | — | — | — |
| Lower respiratory tract infection [U] | Infections and infestations | — | — | — |
| Nasopharyngitis [U] | Infections and infestations | — | — | — |
| Staphyloccal infection [I] | Infections and infestations | — | — | — |
| Incision site haematoma [U] | Injury, poisoning and procedural complications | — | — | — |
| Incision site hypoaesthesia [I] | Injury, poisoning and procedural complications | — | — | — |
| Post procedural haemorrhage [U] | Injury, poisoning and procedural complications | — | — | — |
| Procedural headache [S] | Injury, poisoning and procedural complications | — | — | — |
| Procedural nausea [U] | Injury, poisoning and procedural complications | — | — | — |
| Arthralgia [U] | Musculoskeletal and connective tissue disorders | — | — | — |
| Back pain [U] | Musculoskeletal and connective tissue disorders | — | — | — |
| Muscle spasms [S] | Musculoskeletal and connective tissue disorders | — | — | — |
| Muscle tightness [SI] | Musculoskeletal and connective tissue disorders | — | — | — |
| Muscle twitching [S] | Musculoskeletal and connective tissue disorders | — | — | — |
| Myalgia [I] | Musculoskeletal and connective tissue disorders | — | — | — |
| Pain in extremety [I] | Musculoskeletal and connective tissue disorders | — | — | — |
| Pain in jaw [U] [S] | Musculoskeletal and connective tissue disorders | — | — | — |
| Convulsion [U] | Nervous system disorders | — | — | — |
| Headache [U] | Nervous system disorders | — | — | — |
| Migraine [U] | Nervous system disorders | — | — | — |
Most-reported serious reactions: Peripheral arterial occlusive disease.
Data from ClinicalTrials.gov NCT02385526 adverse events section.
Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive VNS Therapy using new titration protocols.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing