Trigeminal NeuralgiaPhase 2NCT02473016
Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia
A Phase 2 study testing Carbon Dioxide Drug Delivery System (CDDS) in people with Trigeminal Neuralgia, run by Capnia, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Carbon Dioxide Drug Delivery System (CDDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2015to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22903
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
Columbia University Medical Center
New York, New York, 10032
University of Pittsbugh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Meridien Research
Tampa, Florida, 33634
About this study
Official title: 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Carbon Dioxide Drug Delivery System (CDDS)
- Keywords
- Classical Trigeminal Neuralgia
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Dioxide Drug Delivery System (CDDS)Drug
Also called Nasal CO2, Nasal Carbon Dioxide
Doses will be administered to the nostril on the side of the trigeminal episode [ipsilateral nostril].
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Drug: Carbon Dioxide Drug Delivery System (CDDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief assessed on a visual analog scale (VAS) in a subject diary
Measured: Assessed through 24 hours from initial dose
Secondary outcomes (10)
Percentage of subjects experiencing pain freedom at 5-60 minutes assessed on a visual analog scale (VAS) in a subject diary
Measured: Assessed through 60 minutes post intial dose
Reduction in the number of attacks (recorded in a subject diary)
Measured: Assessed through 24 hours from initial dose
Increase in duration between episodes of pain (recorded in a subject diary)
Measured: 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
Measured: Assessed through 60 minutes post intial dose
Rescue medication usage (recorded in a subject diary)
Measured: Assessed through 24 hours from initial dose
Subject satisfaction (recorded in a subject diary)
Measured: Assessed through 24 hours from initial dose
Attack recurrence (recorded in a subject diary)
Measured: Assessed through 24 hours from initial dose
Decreased trigger sensitivity (recorded in a subject diary)
Measured: Assessed through 24 hours from initial dose
Reported Adverse Events (recorded in a subject diary and during follow up phone calls)
Measured: Up to 7 days after inital dose
Reduction in intensity of attacks (recorded in a subject diary)
Measured: Assessed through 24 hours from initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capnia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473016
- Sponsor's protocol ID
- C402
- Status last verified
- Nov 2017
- First submitted
- 29 May 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Single-Blind Study Evaluating the Safety and Efficacy of Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT02473016
- Acronym / sponsor ID
- C402
- Conditions
- Trigeminal Neuralgia
- Keywords
- Classical Trigeminal Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Capnia, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Carbon Dioxide Drug Delivery System (CDDS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Dioxide Drug Delivery System (CDDS)Also: Nasal CO2, Nasal Carbon DioxideDoses will be administered to the nostril on the side of the trigeminal episode [ipsilateral nostril]. | Drug | Treatment |
Primary outcome
Pain relief assessed on a visual analog scale (VAS) in a subject diary
Time frame: Assessed through 24 hours from initial dose
10 secondary outcomes
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
Reduction in the number of attacks (recorded in a subject diary)
Time frame: 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
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
Rescue medication usage (recorded in a subject diary)
Time frame: Assessed through 24 hours from initial dose
Subject satisfaction (recorded in a subject diary)
Time frame: Assessed through 24 hours from initial dose
Attack recurrence (recorded in a subject diary)
Time frame: Assessed through 24 hours from initial dose
Decreased trigger sensitivity (recorded in a subject diary)
Time frame: 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
Reduction in intensity of attacks (recorded in a subject diary)
Time frame: Assessed through 24 hours from initial dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbon Dioxide Drug Delivery System (CDDS) in people with Trigeminal Neuralgia, run by Capnia, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief assessed on a visual analog scale (VAS) in a subject diary (time frame: Assessed through 24 hours from initial dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.