High Frequency Episodic Migraine and Chronic MigrainePhase 2NCT01839149
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
A Phase 2 study testing TI-001 in people with High Frequency Episodic Migraine and Chronic Migraine, run by Trigemina, Inc at 6 sites in 3 countries.
Trial summary
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Frequency Episodic Migraine and Chronic Migraine
- What is being tested?
- TI-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2013to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.
Who cannot join
- Known allergy to oxytocin
- History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
- History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
- Have basilar or hemiplegic migraines
- Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
- Have a nasal obstruction due to any cause
Show all 9Show fewer
- Are pregnant or breast feeding
- Require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs
- Are unable or unwilling to provide informed consent or to follow study procedures
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
About this study
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
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
- Being tested
- TI-001, Placebo
- Keywords
- Refractory Chronic Migraine, Medically Intractable Chronic Migraine, Oxytocin, Intranasal oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI-001Drug
Also called Intranasal oxytocin
TI-001 is intranasal oxytocin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TI-001 (intranasal oxytocin) | Experimental | TI-001 is intranasal oxytocin Receives: Drug: TI-001 |
| Placebo | Placebo comparator | Placebo for TI-001 is the same intranasal formulation without oxytocin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of migraine days
Baseline is the 28-day screening period before study drug administration
Measured: Baseline and 28 days of treatment
Secondary outcomes (4)
Mean change of moderate or severe headache days
Measured: Baseline and 28 days of treatment
Proportion of subjects experiencing a ≥50% reduction in migraine days
Measured: Baseline and 28 days of treatment
Mean change in days using rescue medication
Measured: Baseline and 28 days of treatment
Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
Measured: Baseline and 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Frequency Episodic Migraine and Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trigemina, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raquel Izumi, PhD, Study director, Trigemina, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839149
- Sponsor's protocol ID
- TRIG-05
- Status last verified
- May 2016
- First submitted
- 17 Apr 2013
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01839149
- Acronym / sponsor ID
- TRIG-05
- Keywords
- Refractory Chronic Migraine, Medically Intractable Chronic Migraine, Oxytocin, Intranasal oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Trigemina, IncIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TI-001 (intranasal oxytocin) | Experimental | Drug: TI-001TI-001 is intranasal oxytocin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for TI-001 is the same intranasal formulation without oxytocin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.
Key exclusion criteria (9 listed)
- Known allergy to oxytocin
- History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
- History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
- Have basilar or hemiplegic migraines
- Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TI-001Also: Intranasal oxytocinTI-001 is intranasal oxytocin | Drug | TI-001 (intranasal oxytocin) |
| Placebo | Drug | Placebo |
Primary outcome
Mean change of migraine days
Time frame: Baseline and 28 days of treatment
Baseline is the 28-day screening period before study drug administration
4 secondary outcomes
Mean change of moderate or severe headache days
Time frame: Baseline and 28 days of treatment
Proportion of subjects experiencing a ≥50% reduction in migraine days
Time frame: Baseline and 28 days of treatment
Mean change in days using rescue medication
Time frame: Baseline and 28 days of treatment
Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
Time frame: Baseline and 28 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Izumi, PhD study director
Trigemina, Inc
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TI-001 in people with High Frequency Episodic Migraine and Chronic Migraine, run by Trigemina, Inc at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, New Zealand, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of migraine days (time frame: Baseline and 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.