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 Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Doses will be administered to the nostril on the side of the trigeminal episode \[ipsilateral nostril\].
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
Pain relief assessed on a visual analog scale (VAS) in a subject diary
Time frame: Assessed through 24 hours from initial dose
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
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