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TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
Plain-language guide to NCT01839149: phase 2 randomized trial of Oxytocin, migraine, 240 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01839149
- Phase
- phase 2
- Status
- completed
- Start
- 2013-05
- Completion (planned or actual)
- 2015-10
- Participants
- 240 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- High Frequency Episodic Migraine and Chronic Migraine
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Oxytocin for migraine.
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
It had two arms (groups): TI-001 (intranasal oxytocin) (experimental) and Placebo (placebo comparator).
TI-001 is intranasal oxytocin.
Placebo for TI-001 is the same intranasal formulation without oxytocin.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 240 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 9 exclusion criteria; among the exclusions: known allergy to oxytocin; history of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder; have basilar or hemiplegic migraines.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
The migraine participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
The Oxytocin group and the comparison group ran side by side rather than switching.
As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2013-05 with completion listed for 2015-10.
It ran at 6 sites in Australia (3), New Zealand (2) and Chile (1).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean change of migraine days (time frame: Baseline and 28 days of treatment).
It also tracked 4 secondary outcomes, for example Mean change of moderate or severe headache days and Mean change in days using rescue medication.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Oxytocin in 240 people with migraine.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, Migraine research.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.