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Trial record 62 of 231 for:    CALCITONIN SALMON

Pain Biomarker Study (PBS)

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ClinicalTrials.gov Identifier: NCT03511846
Recruitment Status : Active, not recruiting
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Mark J Burish, The University of Texas Health Science Center, Houston

Brief Summary:

This study investigates molecular and physical biomarkers of headaches in order to better understand mechanisms of these diseases.

There are 3 main parts:

  1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of calcitonin gene related peptide - the hypothesis is that this will be different in headache subjects compared to controls (and if so might be used to predict how these patients will respond to certain medications that modulate calcitonin gene-related peptide). Subjects will be given capsaicin as a cream applied to the forehead or the inner nostril, or a hot sauce that is ingested.
  2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow down the amount of eye watering. Cluster headache patients respond very powerfully to oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents there is data that it works on the parasympathetic / lacrimal gland system. This study translates rodent data into humans in a non-invasive way to confirm the mechanism of this very effective treatment.
  3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but intense headache that may cause similar biomarker release as other headache disorders. This may be a useful human model for other headache disorders.

Condition or disease Intervention/treatment Phase
Migraine Cluster Headache Trigeminal Autonomic Cephalgia Hemicrania Continua Paroxysmal Hemicrania SUNCT Short-Lasting Unilateral Neuralgiform Headache With Conjunctival Injection and Tearing Drug: Oral capsaicin Drug: Topical capsaicin Drug: Intranasal capsaicin Other: Cold Water Irrigation Other: Medical Air Drug: Low Flow Oxygen Drug: High Flow Oxygen Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 371 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: In the oxygen portion of the study, subjects and the outcomes assessors will be told that they will be receiving either medical air or oxygen.
Primary Purpose: Basic Science
Official Title: The Pain Biomarker Study: Changes in Circulating Pain Signalling Molecules With Activation of Pain Receptors
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Oral capsaicin Drug: Oral capsaicin
Subjects will drink a solution with capsaicin

Sham Comparator: Oral capsaicin and Medical Air Drug: Oral capsaicin
Subjects will drink a solution with capsaicin

Other: Medical Air
Subjects will be exposed to medical air

Experimental: Oral Capsaicin and Low Flow Oxygen Drug: Oral capsaicin
Subjects will drink a solution with capsaicin

Drug: Low Flow Oxygen
Subjects will be exposed to oxygen gas between 1-9 L/min

Experimental: Oral capsaicin and High Flow Oxygen Drug: Oral capsaicin
Subjects will drink a solution with capsaicin

Drug: High Flow Oxygen
Subjects will be exposed to oxygen gas between 10-25 L/min

Experimental: Topical capsaicin Drug: Topical capsaicin
Capsaicin cream will be applied to the skin of the forehead, cheek, or leg

Sham Comparator: Topical capsaicin and Medical Air Drug: Topical capsaicin
Capsaicin cream will be applied to the skin of the forehead, cheek, or leg

Other: Medical Air
Subjects will be exposed to medical air

Experimental: Topical capsaicin and Low Flow Oxygen Drug: Topical capsaicin
Capsaicin cream will be applied to the skin of the forehead, cheek, or leg

Drug: Low Flow Oxygen
Subjects will be exposed to oxygen gas between 1-9 L/min

Experimental: Topical capsaicin and High Flow Oxygen Drug: Topical capsaicin
Capsaicin cream will be applied to the skin of the forehead, cheek, or leg

Drug: High Flow Oxygen
Subjects will be exposed to oxygen gas between 10-25 L/min

Experimental: Intranasal capsaicin Drug: Intranasal capsaicin
Capsaicin cream will be applied to the nostril

Sham Comparator: Intranasal capsaicin and Medical Air Drug: Intranasal capsaicin
Capsaicin cream will be applied to the nostril

Other: Medical Air
Subjects will be exposed to medical air

Experimental: Intranasal capsaicin and Low Flow Oxygen Drug: Intranasal capsaicin
Capsaicin cream will be applied to the nostril

Drug: Low Flow Oxygen
Subjects will be exposed to oxygen gas between 1-9 L/min

Experimental: Intranasal capsaicin and High Flow Oxygen Drug: Intranasal capsaicin
Capsaicin cream will be applied to the nostril

Drug: High Flow Oxygen
Subjects will be exposed to oxygen gas between 10-25 L/min

Experimental: Cold water irrigation Other: Cold Water Irrigation
Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)

Sham Comparator: Cold water irrigation and Medical Air Other: Cold Water Irrigation
Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)

Other: Medical Air
Subjects will be exposed to medical air

Experimental: Cold water irrigation and Low Flow Oxygen Other: Cold Water Irrigation
Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)

Drug: Low Flow Oxygen
Subjects will be exposed to oxygen gas between 1-9 L/min

Experimental: Cold water irrigation and High Flow Oxygen Other: Cold Water Irrigation
Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)

Drug: High Flow Oxygen
Subjects will be exposed to oxygen gas between 10-25 L/min




Primary Outcome Measures :
  1. Activation of trigeminoautonomic reflex as assessed by change in Calcitonin gene-related peptide (CGRP) levels from before stimulation to after stimulation. [ Time Frame: 10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation ]
  2. Activation of trigeminoautonomic reflex as assessed by tear fluid production [ Time Frame: 90 minutes after pain stimulation ]
    The amount of tear fluid after each intervention will be measured via Schirmer strips


Secondary Outcome Measures :
  1. Activation of trigeminoautonomic reflex as assessed by change in pituitary adenylate cyclase activating polypeptide-38 (PACAP-38) levels levels from before stimulation to after stimulation. [ Time Frame: 10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation ]
  2. Activation of trigeminoautonomic reflex as assessed by saliva production [ Time Frame: 90 minutes after pain stimulation ]
  3. Activation of trigeminoautonomic reflex as assessed by nasal fluid production [ Time Frame: 90 minutes after pain stimulation ]
  4. Activation of trigeminoautonomic reflex as assessed by tactile threshold measurement with von Frey Filaments [ Time Frame: 90 minutes after pain stimulation ]
  5. Activation of trigeminoautonomic reflex as assessed by dermal blood flow [ Time Frame: 90 minutes after pain stimulation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of one of the following: a. Diagnosis of a primary headache disorder according to the International Headache Classification, including migraine with aura, migraine without aura, chronic migraine, tension headache, cluster headache, paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT), short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA), and hemicrania continua; b. Diagnosed by a pain medicine physician with lumbar radiculopathy (possibly including neuropathic features, nerve impingement on MRI, or electromyography (EMG) report suggestive of lumbar radiculopathy); or c. Healthy control subject with no history of debilitating headaches or debilitating back pain / radiculopathy pain, and no headaches or back pain within the previous 3 months.
  • Able to provide HIPAA authorization to share prior medical records/imaging
  • Age 18 and older

Exclusion Criteria:

  • The following items exclude the subject from all portions of the study: a. Known history of cardiovascular or neurovascular diseases. These diseases may include carotid stenosis of >50%, vertebral stenosis, peripheral vascular disease, angina or myocardial infarction, stroke, or vascular malformations; b. History of brain tumors or epilepsy; c. Active pregnancy or lactation; d. Daily cigarette, tobacco or nicotine use; e. Life expectancy less than 1 year, co-existing disease or other characteristic that precludes appropriate diagnosis of headache or spine pain; f. Active drug / alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements; or g. Inability or unwillingness of subject to give informed consent (e.g., ward of the state)
  • The following items exclude the subject only from the capsaicin portion of the study: a. Known allergy to capsaicin or hot peppers
  • The following items exclude the subject only from the oxygen portion of the study: a. Pulmonary or other non-headache diseases that require the use of supplemental oxygen
  • The following items exclude the subject only from the cold water irrigation (ice water) portion of the study: a. Trauma, fractures, or congenital abnormalities of the soft palate

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): NCT03511846


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of California, San Francisco
Investigators
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Principal Investigator: Mark Burish, MD PhD The University of Texas Health Science Center, Houston

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Responsible Party: Mark J Burish, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03511846     History of Changes
Other Study ID Numbers: HSC-MS-17-0763
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mark J Burish, The University of Texas Health Science Center, Houston:
Brain Freeze
Capsaicin
Additional relevant MeSH terms:
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Cluster Headache
Anencephaly
Paroxysmal Hemicrania
Trigeminal Autonomic Cephalalgias
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations
Abnormalities, Severe Teratoid
Congenital Abnormalities
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs