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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01839149




Registration number
NCT01839149
Ethics application status
Date submitted
17/04/2013
Date registered
24/04/2013
Date last updated
13/05/2016

Titles & IDs
Public title
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
Scientific 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
Secondary ID [1] 0 0
TRIG-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Frequency Episodic Migraine and Chronic Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TI-001
Treatment: Drugs - Placebo

Experimental: TI-001 (intranasal oxytocin) - TI-001 is intranasal oxytocin

Placebo Comparator: Placebo - Placebo for TI-001 is the same intranasal formulation without oxytocin


Treatment: Drugs: TI-001
TI-001 is intranasal oxytocin

Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change of migraine days
Timepoint [1] 0 0
Baseline and 28 days of treatment
Secondary outcome [1] 0 0
Mean change of moderate or severe headache days
Timepoint [1] 0 0
Baseline and 28 days of treatment
Secondary outcome [2] 0 0
Proportion of subjects experiencing a =50% reduction in migraine days
Timepoint [2] 0 0
Baseline and 28 days of treatment
Secondary outcome [3] 0 0
Mean change in days using rescue medication
Timepoint [3] 0 0
Baseline and 28 days of treatment
Secondary outcome [4] 0 0
Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
Timepoint [4] 0 0
Baseline and 28 days of treatment

Eligibility
Key inclusion criteria
1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic
migraine or chronic migraine.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment hospital [2] 0 0
- Prahran
Recruitment hospital [3] 0 0
- Sherwood
Recruitment postcode(s) [1] 0 0
- Fitzroy
Recruitment postcode(s) [2] 0 0
- Prahran
Recruitment postcode(s) [3] 0 0
- Sherwood
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
New Zealand
State/province [2] 0 0
Tauranga
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Trigemina, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high
frequency episodic migraine and chronic migraine.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01839149
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Raquel Izumi, PhD
Address 0 0
Trigemina, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01839149