TI-001 (Intranasal Oxytocin) for Treatment of Chronic Migraine

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Trigemina, Inc
Sponsor:
Information provided by (Responsible Party):
Trigemina, Inc
ClinicalTrials.gov Identifier:
NCT01839149
First received: April 17, 2013
Last updated: January 12, 2014
Last verified: January 2014
  Purpose

This study evaluates the use of oxytocin, given as a nasal spray, for treatment of chronic migraine.


Condition Intervention Phase
Chronic Migraine
Drug: TI-001
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Enriched-enrollment, Randomized-withdrawal, Double-blinded, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Intranasal Oxytocin in Subjects With Chronic Migraine

Resource links provided by NLM:


Further study details as provided by Trigemina, Inc:

Primary Outcome Measures:
  • Mean reduction in migraine headache days [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    Baseline is the 28-day screening period before enrollment in the study


Secondary Outcome Measures:
  • Change in migraine pain scores measured with a 4-point verbal rating scale [ Time Frame: baseline (before study drug administration) and 2 hours after dosing ] [ Designated as safety issue: No ]
    Measured for every migraine episode during the open-label phase that consists of 28 days of active treatment for all enrolled subjects and during the randomized, double-blind phase. Subjects are randomzied to either placebo or active and treated for 28-days during the double-blind phase.

  • Frequency of nausea [ Time Frame: 28 days (double-blind treatment period) ] [ Designated as safety issue: No ]
  • Frequency of photophobia [ Time Frame: 28 days (double-blind treatment period) ] [ Designated as safety issue: No ]
  • Frequency of phonophobia [ Time Frame: 28 days (double-blind treatment period) ] [ Designated as safety issue: No ]
  • Frequency of migraine episodes [ Time Frame: 28 days (double-blind treatment period) ] [ Designated as safety issue: No ]
  • Time to study discontinuation due to any cause [ Time Frame: 28 days (double-blind treatment period) ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    This study has an open-label phase of 28 days wherein all subjects receive active drug and dose titrate to effect. Then they are randomized to active or placebo for an additional 28 days of treatment. Therefore safety is measured for the entire 56 days.


Other Outcome Measures:
  • Interleukin-6 (IL-6) levels as a marker of response [ Time Frame: measured at screening only ] [ Designated as safety issue: No ]
    The screening period of this study is 28 days. But this blood test is done only once any time during the screening period before first dose.


Estimated Enrollment: 240
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TI-001 (intranasal oxytocin)
TI-001 is intranasal oxytocin administered at 15 to 60 IU per dose.
Drug: TI-001
TI-001 is intranasal oxytocin administered at 15 to 60 IU per dose.
Other Name: Intranasal oxytocin
Placebo Comparator: Placebo
Placebo for TI-001 is the same intranasal formulation without oxytocin.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, aged 18 to 80 years
  2. Primary diagnosis of chronic migraine based on the International Headache Society definition as defined below:

    1. Migraine headache without aura occurring on ≥15 days per month for > 3 months and fulfilling criteria b-d below:
    2. Headache has ≥ 2 of the following criteria:

    i. Unilateral location ii. Pulsating quality iii. Severe pain intensity iv. Aggravation by or causing avoidance of routine physical activity c. During headache ≥ 1 of the following: i. Nausea and/or vomiting ii. Photophobia and phonophobia d. Not attributed to another disorder

  3. Currently experiencing migraine headaches of at least 4 hours in duration, which are severe in pain intensity while on standard of care (eg, triptans and ergotamines)

Exclusion Criteria:

  1. Known allergy to oxytocin
  2. History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
  3. History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
  4. Have basilar or hemiplegic migraines
  5. Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
  6. Have a nasal obstruction due to any cause
  7. Are pregnant or breast feeding
  8. Require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs
  9. Are unable or unwilling to provide informed consent or to follow study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839149

Contacts
Contact: Eugenio Silva 56 9 9279 3451 esilva@trigemina.com
Contact: Maria Luisa Bustos 56 9 9799 0956 mlbustos@trigemina.com

Locations
Australia
Recruiting
Sherwood, Australia
Chile
Recruiting
Santiago, Chile
Sponsors and Collaborators
Trigemina, Inc
Investigators
Study Director: Raquel Izumi, PhD Trigemina, Inc
  More Information

No publications provided

Responsible Party: Trigemina, Inc
ClinicalTrials.gov Identifier: NCT01839149     History of Changes
Other Study ID Numbers: TRIG-05
Study First Received: April 17, 2013
Last Updated: January 12, 2014
Health Authority: Chile: Institute of Public Health (Instituto de Salud Pública de Chile)

Keywords provided by Trigemina, Inc:
Refractory Chronic Migraine
Medically Intractable Chronic Migraine
Oxytocin
Intranasal oxytocin

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014