Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia

November 16, 2017 updated by: Capnia, Inc.

A Placebo-Controlled, Single-Blind Study Evaluating the Safety and Efficacy of Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles (UCLA)
    • Florida
      • Tampa, Florida, United States, 33634
        • Meridien Research
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsbugh Medical Center (UPMC)
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
All subjects will receive both Active (Carbon Dioxide Drug Delivery System) and Placebo. This is a single-blind study so subjects will not know the order. Subjects will receive 3 doses of active and 3 doses of placebo. One dose is a 60 second delivery of CO2 or placebo. At the discretion of the investigator, subjects may receive up to 3 additional doses of CO2.
Drug: Carbon Dioxide Drug Delivery System (CDDS)
Doses will be administered to the nostril on the side of the trigeminal episode [ipsilateral nostril].
Other Names:
  • Nasal CO2
  • Nasal Carbon Dioxide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pain relief assessed on a visual analog scale (VAS) in a subject diary
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of subjects experiencing pain freedom at 5-60 minutes assessed on a visual analog scale (VAS) in a subject diary
Time Frame: Assessed through 60 minutes post intial dose
Assessed through 60 minutes post intial dose
Reduction in the number of attacks (recorded in a subject diary)
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose
Increase in duration between episodes of pain (recorded in a subject diary)
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose
Percentage of subjects with pain relief 5-60 minutes assessed on a visual analog scale (VAS) in a subject diary
Time Frame: Assessed through 60 minutes post intial dose
Assessed through 60 minutes post intial dose
Rescue medication usage (recorded in a subject diary)
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose
Subject satisfaction (recorded in a subject diary)
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose
Attack recurrence (recorded in a subject diary)
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose
Decreased trigger sensitivity (recorded in a subject diary)
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose
Reported Adverse Events (recorded in a subject diary and during follow up phone calls)
Time Frame: Up to 7 days after inital dose
Up to 7 days after inital dose
Reduction in intensity of attacks (recorded in a subject diary)
Time Frame: Assessed through 24 hours from initial dose
Assessed through 24 hours from initial dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capnia, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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