Chronic Daily Headache
Conditions
Keywords
intranasal oxytocin, acute headache treatment, chronic daily headache
Brief summary
The objective of this prospective, randomized, double-blind, parallel-group, placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects suffering from chronic daily headache.
Detailed description
The TI004 and TI005 studies both used a randomized, double-blind, placebo-controlled, parallel-group study design. A protocol-specified interim analysis was performed after completion of the first 40 subjects, resulting in termination of the TI004 study and development of the TI005 protocol, which included the following changes from the TI004 protocol: 1. Increase in oxytocin dose from 32 to 64 IU; 2. Extension of the in-clinic observation period from 2 hours post-dose to 4-hours post-dose; 3. Reduction in sample size from 40 to 20 subjects; 4. Elimination of the laboratory measurements during the screening visit, allowing V1 and V2 potentially to be combined, expediting study completion; 5. Adding in-clinic observation and assessment at 3 hours and 4 hours post-dose and out-of-clinic assessment at 8 hours post-dose. The primary outcome measure is the reduction in headache intensity after drug administration; secondary outcome measures are the headache symptoms, nausea, vomiting, photophobia, and phonophobia. Additional secondary outcome measures are intake of rescue medication and patient satisfaction over a period of 24 hours.
Interventions
DRUGSyntocinon
4 actuations in each nostril for a total dose of 32 IU
DRUGSterile water
4 actuations in each nostril
Sponsors
MedVadis Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension. 2. More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale. 3. Headaches typically last for at least 4 hours. 4. Subjects are on a stable headache treatment, if any, for at least 2 months.
Exclusion criteria
1. Headache symptoms assessed to be predominately occipital. 2. Allergy to oxytocin. 3. History of addictive behavior (e.g. alcoholism, drug abuse). 4. History of significant psychiatric disorder. 5. History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease. 6. Upper-respiratory tract infection at the time of randomization. 7. Past or current history of any condition that may hinder study procedures or confuse interpretation of data. 8. Nasal obstruction of any cause as determined at screening. 9. Major surgery or trauma within 4 weeks of screening. 10. Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive. 11. Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization. 12. Use of an investigational medication or device within 30 days of randomization. 13. Unable or unwilling to adhere to the study-specific procedures and restrictions. 14. Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data. 15. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN). 16. Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Headache Intensity | 2 hours after administration of study medication | Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Headache Intensity | ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale) |
| Average Headache Intensity | ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible). |
| Presence of Nausea, Vomiting, Photophobia, and Phonophobia | ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Number (percentage) of participants with effects of oxytocin on symptoms associated with chronic daily headache, such as nausea, vomiting, photophobia, and phonophobia |
| Intake of Rescue Medication | Up to 24 hours after intervention administration | Number of participants who took rescue medication (examples: ibuprofen, Tylenol, zolmitriptan) for headache at any time within the 24 hours after intervention administration. |
| Participant Satisfaction | Up to 24 hours after intervention administration | Participants rated their satisfaction with treatment on a 4-point scale as Excellent, Good, Moderate, or Poor. Number (percentage) of participants who reported each rating. |
Countries
United States
Participant flow
Recruitment details
Subjects recruited at dedicated research center
Pre-assignment details
In total 79 subjects were screened, of which five were screen failures in the strict sense of the word and 14 were not randomized because the 6-week treatment period had elapsed.
Participants by arm
| Arm | Count |
|---|---|
| Syntocinon® (Oxytocin) TI-004 Protocol 32 IU intranasally | 22 |
| Placebo TI-004 Protocol Sterile water intranasally | 18 |
| Syntocinon® (Oxytocin) TI-005 Protocol 64 IU intranasally | 12 |
| Placebo TI-005 Protocol Sterile water intranasally | 8 |
| Total | 60 |
Baseline characteristics
| Characteristic | Syntocinon® (Oxytocin) TI-004 Protocol | Placebo TI-004 Protocol | Syntocinon® (Oxytocin) TI-005 Protocol | Placebo TI-005 Protocol | Total |
|---|---|---|---|---|---|
| Age, Continuous Protocol TI-004 | 44.5 years STANDARD_DEVIATION 11.37 | 41.0 years STANDARD_DEVIATION 9.4 | NA years | NA years | 42.9 years STANDARD_DEVIATION 10.6 |
| Age, Continuous Protocol TI-005 | NA years | NA years | 45.0 years STANDARD_DEVIATION 10.8 | 39.5 years STANDARD_DEVIATION 15.1 | 42.8 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 17 Participants | 12 Participants | 8 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 0 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 12 Participants | 8 Participants | 20 Participants |
| Race (NIH/OMB) White | 12 Participants | 10 Participants | 0 Participants | 0 Participants | 22 Participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 6 Participants | 3 Participants | 36 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 6 Participants | 5 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 18 | 0 / 12 | 0 / 8 |
| other Total, other adverse events | 8 / 22 | 3 / 18 | 2 / 12 | 1 / 8 |
| serious Total, serious adverse events | 0 / 22 | 0 / 18 | 0 / 12 | 0 / 8 |
Outcome results
Primary
Reduction in Headache Intensity
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Time frame: 2 hours after administration of study medication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Syntocinon® (Oxytocin) TI-004 Protocol | Reduction in Headache Intensity | 6 Participants |
| Placebo TI-004 Protocol | Reduction in Headache Intensity | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Reduction in Headache Intensity | 1 Participants |
| Placebo TI-005 Protocol | Reduction in Headache Intensity | 3 Participants |
Secondary
Average Headache Intensity
Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Time frame: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Population: Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon® (Oxytocin) TI-004 Protocol | Average Headache Intensity | 0.5 hours after administration | 7.1 score on a scale | Standard Deviation 1.5 |
| Syntocinon® (Oxytocin) TI-004 Protocol | Average Headache Intensity | 4 hours after administration | 3.8 score on a scale | Standard Deviation 2.9 |
| Syntocinon® (Oxytocin) TI-004 Protocol | Average Headache Intensity | 24 hours after administration | 4.2 score on a scale | Standard Deviation 2.8 |
| Syntocinon® (Oxytocin) TI-004 Protocol | Average Headache Intensity | 2 hours after administration | 5.8 score on a scale | Standard Deviation 2.2 |
| Syntocinon® (Oxytocin) TI-004 Protocol | Average Headache Intensity | 1 hour after administration | 6.2 score on a scale | Standard Deviation 2.3 |
| Placebo TI-004 Protocol | Average Headache Intensity | 2 hours after administration | 5.9 score on a scale | Standard Deviation 1.7 |
| Placebo TI-004 Protocol | Average Headache Intensity | 4 hours after administration | 6.0 score on a scale | Standard Deviation 1.9 |
| Placebo TI-004 Protocol | Average Headache Intensity | 1 hour after administration | 6.5 score on a scale | Standard Deviation 1.3 |
| Placebo TI-004 Protocol | Average Headache Intensity | 0.5 hours after administration | 7.1 score on a scale | Standard Deviation 1.6 |
| Placebo TI-004 Protocol | Average Headache Intensity | 24 hours after administration | 4.5 score on a scale | Standard Deviation 3 |
| Syntocinon® (Oxytocin) TI-005 Protocol | Average Headache Intensity | 3 hours after administration | 4.8 score on a scale | Standard Deviation 1.7 |
| Syntocinon® (Oxytocin) TI-005 Protocol | Average Headache Intensity | 0.5 hours after administration | 6.5 score on a scale | Standard Deviation 0.8 |
| Syntocinon® (Oxytocin) TI-005 Protocol | Average Headache Intensity | 1 hour after administration | 6.1 score on a scale | Standard Deviation 1.1 |
| Syntocinon® (Oxytocin) TI-005 Protocol | Average Headache Intensity | 2 hours after administration | 5.7 score on a scale | Standard Deviation 1.1 |
| Syntocinon® (Oxytocin) TI-005 Protocol | Average Headache Intensity | 4 hours after administration | 3.9 score on a scale | Standard Deviation 2.6 |
| Syntocinon® (Oxytocin) TI-005 Protocol | Average Headache Intensity | 8 hours after administration | 4.3 score on a scale | Standard Deviation 2.5 |
| Syntocinon® (Oxytocin) TI-005 Protocol | Average Headache Intensity | 24 hours after administration | 3.5 score on a scale | Standard Deviation 3 |
| Placebo TI-005 Protocol | Average Headache Intensity | 4 hours after administration | 2.8 score on a scale | Standard Deviation 2.2 |
| Placebo TI-005 Protocol | Average Headache Intensity | 24 hours after administration | 1.8 score on a scale | Standard Deviation 2.8 |
| Placebo TI-005 Protocol | Average Headache Intensity | 8 hours after administration | 3.0 score on a scale | Standard Deviation 2.3 |
| Placebo TI-005 Protocol | Average Headache Intensity | 1 hour after administration | 5.7 score on a scale | Standard Deviation 1.8 |
| Placebo TI-005 Protocol | Average Headache Intensity | 3 hours after administration | 3.5 score on a scale | Standard Deviation 2.1 |
| Placebo TI-005 Protocol | Average Headache Intensity | 2 hours after administration | 4.6 score on a scale | Standard Deviation 1.9 |
| Placebo TI-005 Protocol | Average Headache Intensity | 0.5 hours after administration | 6.1 score on a scale | Standard Deviation 1.2 |
Secondary
Intake of Rescue Medication
Number of participants who took rescue medication (examples: ibuprofen, Tylenol, zolmitriptan) for headache at any time within the 24 hours after intervention administration.
Time frame: Up to 24 hours after intervention administration
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Syntocinon® (Oxytocin) TI-004 Protocol | Intake of Rescue Medication | 12 Participants |
| Placebo TI-004 Protocol | Intake of Rescue Medication | 10 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Intake of Rescue Medication | 4 Participants |
| Placebo TI-005 Protocol | Intake of Rescue Medication | 2 Participants |
Secondary
Participant Satisfaction
Participants rated their satisfaction with treatment on a 4-point scale as Excellent, Good, Moderate, or Poor. Number (percentage) of participants who reported each rating.
Time frame: Up to 24 hours after intervention administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Syntocinon® (Oxytocin) TI-004 Protocol | Participant Satisfaction | Poor satisfaction rating | 4 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Participant Satisfaction | Excellent satisfaction rating | 4 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Participant Satisfaction | Good satisfaction rating | 7 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Participant Satisfaction | Moderate satisfaction rating | 6 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Participant Satisfaction | Satisfaction rating not reported | 1 Participants |
| Placebo TI-004 Protocol | Participant Satisfaction | Moderate satisfaction rating | 4 Participants |
| Placebo TI-004 Protocol | Participant Satisfaction | Poor satisfaction rating | 2 Participants |
| Placebo TI-004 Protocol | Participant Satisfaction | Good satisfaction rating | 5 Participants |
| Placebo TI-004 Protocol | Participant Satisfaction | Excellent satisfaction rating | 5 Participants |
| Placebo TI-004 Protocol | Participant Satisfaction | Satisfaction rating not reported | 2 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Participant Satisfaction | Moderate satisfaction rating | 2 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Participant Satisfaction | Excellent satisfaction rating | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Participant Satisfaction | Good satisfaction rating | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Participant Satisfaction | Poor satisfaction rating | 2 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Participant Satisfaction | Satisfaction rating not reported | 0 Participants |
| Placebo TI-005 Protocol | Participant Satisfaction | Moderate satisfaction rating | 0 Participants |
| Placebo TI-005 Protocol | Participant Satisfaction | Good satisfaction rating | 5 Participants |
| Placebo TI-005 Protocol | Participant Satisfaction | Excellent satisfaction rating | 2 Participants |
| Placebo TI-005 Protocol | Participant Satisfaction | Satisfaction rating not reported | 0 Participants |
| Placebo TI-005 Protocol | Participant Satisfaction | Poor satisfaction rating | 1 Participants |
Secondary
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Number (percentage) of participants with effects of oxytocin on symptoms associated with chronic daily headache, such as nausea, vomiting, photophobia, and phonophobia
Time frame: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Population: Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 1 hour | 5 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 24 hours | 9 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 4 hours | 6 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 24 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 4 hours | 2 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 4 hours | 7 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 0.5 hours | 17 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 0.5 hours | 7 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 1 hour | 14 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 2 hours | 10 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 2 hours | 10 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 24 hours | 2 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 24 hours | 4 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 0.5 hours | 1 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 2 hours | 3 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 1 hour | 10 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 1 hour | 0 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 2 hours | 1 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 0.5 hours | 11 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 4 hours | 0 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 0.5 hours | 10 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 24 hours | 2 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 24 hours | 7 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 4 hours | 14 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 1 hour | 12 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 24 hours | 0 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 2 hours | 0 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 0.5 hours | 0 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 24 hours | 5 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 0.5 hours | 15 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 4 hours | 6 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 4 hours | 2 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 4 hours | 10 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 1 hour | 13 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 1 hour | 3 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 2 hours | 13 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 1 hour | 0 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 2 hours | 9 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 0.5 hours | 2 Participants |
| Placebo TI-004 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 2 hours | 2 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 3 hours | 5 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 0.5 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 1 hour | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 2 hours | 1 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 3 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 4 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 8 hours | 1 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 24 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 0.5 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 1 hour | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 2 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 3 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 4 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 8 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 24 hours | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 0.5 hours | 6 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 1 hour | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 2 hours | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 4 hours | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 8 hours | 3 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 24 hours | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 0.5 hours | 6 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 1 hour | 3 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 2 hours | 3 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 3 hours | 3 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 4 hours | 2 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 8 hours | 2 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 24 hours | 3 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 4 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 3 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 0.5 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 24 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 2 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 1 hour | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 4 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 0.5 hours | 2 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 0.5 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 24 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 24 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 1 hour | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 8 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 4 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 8 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 2 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 1 hour | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 1 hour | 2 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Phonophobia at 3 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 2 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 0.5 hours | 3 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 3 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 24 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Vomiting at 8 hours | 0 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 3 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 4 hours | 1 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Nausea at 2 hours | 2 Participants |
| Placebo TI-005 Protocol | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | Photophobia at 8 hours | 1 Participants |
Secondary
Reduction in Headache Intensity
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Time frame: ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Population: Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Syntocinon® (Oxytocin) TI-004 Protocol | Reduction in Headache Intensity | 0.5 hours after administration | 0 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Reduction in Headache Intensity | 1 hour after administration | 3 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Reduction in Headache Intensity | 4 hours after administration | 11 Participants |
| Syntocinon® (Oxytocin) TI-004 Protocol | Reduction in Headache Intensity | 24 hours after administration | 10 Participants |
| Placebo TI-004 Protocol | Reduction in Headache Intensity | 1 hour after administration | 1 Participants |
| Placebo TI-004 Protocol | Reduction in Headache Intensity | 24 hours after administration | 7 Participants |
| Placebo TI-004 Protocol | Reduction in Headache Intensity | 0.5 hours after administration | 1 Participants |
| Placebo TI-004 Protocol | Reduction in Headache Intensity | 4 hours after administration | 2 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Reduction in Headache Intensity | 4 hours after administration | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Reduction in Headache Intensity | 1 hour after administration | 0 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Reduction in Headache Intensity | 3 hours after administration | 1 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Reduction in Headache Intensity | 24 hours after administration | 6 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Reduction in Headache Intensity | 8 hours after administration | 4 Participants |
| Syntocinon® (Oxytocin) TI-005 Protocol | Reduction in Headache Intensity | 0.5 hours after administration | 0 Participants |
| Placebo TI-005 Protocol | Reduction in Headache Intensity | 0.5 hours after administration | 0 Participants |
| Placebo TI-005 Protocol | Reduction in Headache Intensity | 8 hours after administration | 5 Participants |
| Placebo TI-005 Protocol | Reduction in Headache Intensity | 24 hours after administration | 6 Participants |
| Placebo TI-005 Protocol | Reduction in Headache Intensity | 1 hour after administration | 1 Participants |
| Placebo TI-005 Protocol | Reduction in Headache Intensity | 3 hours after administration | 4 Participants |
| Placebo TI-005 Protocol | Reduction in Headache Intensity | 4 hours after administration | 5 Participants |