Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia

Completed · Phase 2

Conditions studied: Trigeminal Neuralgia

In brief

A placebo-controlled, single-blind study to evaluate the safety and preliminary efficacy of nasal carbon dioxide for the symptomatic treatment of classical trigeminal neuralgia.

Key facts

Study ID

NCT02473016

Run by

Capnia, Inc.

People needed

30

Starts

2015-09-01

Expected to finish

2017-04-01

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female, 18 years of age and older.
• History of classical trigeminal neuralgia with or without persistent background facial pain, not secondary, as defined by International Classification of Headache Disorders (ICHD), third edition, beta version (ICHD-3 beta, Cephalalgia 2013).
• Diagnosis of trigeminal neuralgia (TN) for at least 60 days prior to enrollment.
• Experience pain with a score of at least 5 on a 0-10 scale during a typical TN episode as reported by subject. Note: Prior to treatment pain score must a 5 or greater on a VAS.
• History of unilateral typical TN pain predominantly in the V2 branch of the trigeminal nerve.
• Absence of a significant structural lesion (e.g., a tumor) as the cause of pain as shown in at least one neuro-imaging study.
• On stable dose of all medications, including those for the treatment of TN prevention/prophylaxis, for at least 14 days prior to baseline (including, but not limited to, verapamil, lithium, melatonin, any anticonvulsant, any systemic corticosteroid or steroid injection, occipital nerve block, other cranial or extracranial nerve block, or any neurostimulation treatment). Note: Subjects are allowed to use their usual standard of care for the acute/abortive treatment of trigeminal neuralgia attacks 60 or more minutes after the initial dose, provided it is approved by the investigator.
• Capable of completing a diary.
• Able to provide written Informed Consent.

You may not qualify if…

• Are unable to comply with protocol requirements.
• Have recent of alcohol or drug abuse within 2 years prior to study enrollment.
• Current major psychiatric disorder: suicidal ideation, bipolar, panic disorder, schizophrenic, or psychosis. Subjects who are documented as clinically stable and not exhibiting symptoms related to their psychiatric disorder are eligible.
• History of asthma (other than mild or intermittent).
• Have an existing serious unstable systemic disease (e.g., severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation.
• Clinically significant nasal disorder (deviated septum, presence of polyps, evidence of significant congestion, rhinitis, or other nasal abnormalities) that prevents unrestricted breathing through each nostril.
• Currently on anticoagulants or have a diagnosis of a bleeding disorder.
• Current diagnosis of fibromyalgia, temporomandibular disorders (TMD), odontogenic pain or other orofacial pain.
• Surgery for treatment of TN within 30 days prior to screening. Note: Investigator must ensure that patients who have had surgery have recovered and are not experiencing any side effects from surgery for treatment of TN
• Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participation or within 30 days after treatment.
• Participation in a previous study with nasal CO2.
• Participation in another investigational drug study within 30 days prior to randomization.

Where it is running

• University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• Meridien Research — Tampa, Florida, United States
• Columbia University Medical Center — New York, New York, United States
• University of Pittsbugh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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