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Trial record 13 of 1679 for:    CARBON DIOXIDE AND dioxide

Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia

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ClinicalTrials.gov Identifier: NCT02473016
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Capnia, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Drug: Carbon Dioxide Drug Delivery System (CDDS) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : September 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pain relief assessed on a visual analog scale (VAS) in a subject diary [ Time Frame: Assessed through 24 hours from initial dose ]

Secondary Outcome Measures :
  1. 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 ]
  2. Reduction in the number of attacks (recorded in a subject diary) [ Time Frame: Assessed through 24 hours from initial dose ]
  3. Increase in duration between episodes of pain (recorded in a subject diary) [ Time Frame: Assessed through 24 hours from initial dose ]
  4. 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 ]
  5. Rescue medication usage (recorded in a subject diary) [ Time Frame: Assessed through 24 hours from initial dose ]
  6. Subject satisfaction (recorded in a subject diary) [ Time Frame: Assessed through 24 hours from initial dose ]
  7. Attack recurrence (recorded in a subject diary) [ Time Frame: Assessed through 24 hours from initial dose ]
  8. Decreased trigger sensitivity (recorded in a subject diary) [ Time Frame: Assessed through 24 hours from initial dose ]
  9. Reported Adverse Events (recorded in a subject diary and during follow up phone calls) [ Time Frame: Up to 7 days after inital dose ]
  10. Reduction in intensity of attacks (recorded in a subject diary) [ Time Frame: Assessed through 24 hours from initial dose ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473016


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

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Responsible Party: Capnia, Inc.
ClinicalTrials.gov Identifier: NCT02473016     History of Changes
Other Study ID Numbers: C402
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Capnia, Inc.:
Classical Trigeminal Neuralgia
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases