Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473016
• Other study ID #: C402
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2015
• Last updated: November 16, 2017
• Start date: September 2015
• Est. completion date: April 2017

Study information

• Verified date: November 2017
• Source: Capnia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• Carbon Dioxide Drug Delivery System (CDDS)
Doses will be administered to the nostril on the side of the trigeminal episode [ipsilateral nostril].

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Capnia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief assessed on a visual analog scale (VAS) in a subject diary		Assessed through 24 hours from initial dose
Secondary	Percentage of subjects experiencing pain freedom at 5-60 minutes assessed on a visual analog scale (VAS) in a subject diary		Assessed through 60 minutes post intial dose
Secondary	Reduction in the number of attacks (recorded in a subject diary)		Assessed through 24 hours from initial dose
Secondary	Increase in duration between episodes of pain (recorded in a subject diary)		Assessed through 24 hours from initial dose
Secondary	Percentage of subjects with pain relief 5-60 minutes assessed on a visual analog scale (VAS) in a subject diary		Assessed through 60 minutes post intial dose
Secondary	Rescue medication usage (recorded in a subject diary)		Assessed through 24 hours from initial dose
Secondary	Subject satisfaction (recorded in a subject diary)		Assessed through 24 hours from initial dose
Secondary	Attack recurrence (recorded in a subject diary)		Assessed through 24 hours from initial dose
Secondary	Decreased trigger sensitivity (recorded in a subject diary)		Assessed through 24 hours from initial dose
Secondary	Reported Adverse Events (recorded in a subject diary and during follow up phone calls)		Up to 7 days after inital dose
Secondary	Reduction in intensity of attacks (recorded in a subject diary)		Assessed through 24 hours from initial dose