Chronic Daily HeadacheNCT00963040
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
A study testing Syntocinon and Sterile water in people with Chronic Daily Headache, run by MedVadis Research Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Daily Headache
- What is being tested?
- Syntocinon and Sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
- 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.
- Headaches typically last for at least 4 hours.
- Subjects are on a stable headache treatment, if any, for at least 2 months.
Who cannot join
- Headache symptoms assessed to be predominately occipital.
- Allergy to oxytocin.
- History of addictive behavior (e.g. alcoholism, drug abuse).
- History of significant psychiatric disorder.
- History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
- Upper-respiratory tract infection at the time of randomization.
Show all 16Show fewer
- Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
- Nasal obstruction of any cause as determined at screening.
- Major surgery or trauma within 4 weeks of screening.
- Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
- Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
- Use of an investigational medication or device within 30 days of randomization.
- Unable or unwilling to adhere to the study-specific procedures and restrictions.
- Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
- Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedVadis Research Corporation
Wellesley Hills, Massachusetts, 02481
About this study
Official title: The Effect of Intranasal Oxytocin on Headache Intensity and Headache-associated Symptoms in Patients Suffering From Chronic Daily Headache
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.
Read the 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:
- Increase in oxytocin dose from 32 to 64 IU;
- Extension of the in-clinic observation period from 2 hours post-dose to 4-hours post-dose;
- Reduction in sample size from 40 to 20 subjects;
- Elimination of the laboratory measurements during the screening visit, allowing V1 and V2 potentially to be combined, expediting study completion;
- 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.
- Conditions
- Chronic Daily Headache
- Being tested
- Syntocinon, Sterile water
- Keywords
- intranasal oxytocin, acute headache treatment, chronic daily headache
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntocinonDrug
Also called Oxytocin
4 actuations in each nostril for a total dose of 32 IU
Sterile waterDrug
Also called Placebo
4 actuations in each nostril
SyntocinonDrug
Also called Oxytocin
8 actuations in each nostril for a total dose of 64 IU
Sterile waterDrug
Also called Placebo
8 actuations in each nostril
| Study group | Role | What they receive |
|---|---|---|
| Syntocinon® TI-004 protocol | Experimental | Treated group Receives: Drug: Syntocinon |
| Sterile water TI-004 protocol | Placebo comparator | Placebo group Receives: Drug: Sterile water |
| Syntocinon® TI-005 protocol | Experimental | Not described Receives: Drug: Syntocinon |
| Sterile water TI-005 protocol | Placebo comparator | Not described Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours after administration of study medication
Secondary outcomes (5)
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)
Measured: ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Average Headache Intensity
Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Measured: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
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
Measured: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
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.
Measured: Up to 24 hours after intervention administration
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.
Measured: Up to 24 hours after intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Daily HeadacheStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedVadis Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Egilius LH Spierings, MD, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963040
- Sponsor's protocol ID
- TI-004, TI-005
- Status last verified
- Jun 2023
- First submitted
- 18 Aug 2009
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Oxytocin on Headache Intensity and Headache-associated Symptoms in Patients Suffering From Chronic Daily Headache
- ClinicalTrials.gov ID
- NCT00963040
- Acronym / sponsor ID
- TI-004, TI-005
- Conditions
- Chronic Daily Headache
- Keywords
- intranasal oxytocin, acute headache treatment, chronic daily headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MedVadis Research CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Increase in oxytocin dose from 32 to 64 IU;
- Extension of the in-clinic observation period from 2 hours post-dose to 4-hours post-dose;
- Reduction in sample size from 40 to 20 subjects;
- Elimination of the laboratory measurements during the screening visit, allowing V1 and V2 potentially to be combined, expediting study completion;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Syntocinon® TI-004 protocol | Experimental | Drug: SyntocinonTreated group |
| Sterile water TI-004 protocol | Placebo comparator | Drug: Sterile waterPlacebo group |
| Syntocinon® TI-005 protocol | Experimental | Drug: Syntocinon |
| Sterile water TI-005 protocol | Placebo comparator | Drug: Sterile water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
- 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.
- Headaches typically last for at least 4 hours.
- Subjects are on a stable headache treatment, if any, for at least 2 months.
Key exclusion criteria (16 listed)
- Headache symptoms assessed to be predominately occipital.
- Allergy to oxytocin.
- History of addictive behavior (e.g. alcoholism, drug abuse).
- History of significant psychiatric disorder.
- History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
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 |
|---|---|---|
| SyntocinonAlso: Oxytocin4 actuations in each nostril for a total dose of 32 IU | Drug | Syntocinon® TI-004 protocol |
| Sterile waterAlso: Placebo4 actuations in each nostril | Drug | Sterile water TI-004 protocol |
| SyntocinonAlso: Oxytocin8 actuations in each nostril for a total dose of 64 IU | Drug | Syntocinon® TI-005 protocol |
| Sterile waterAlso: Placebo8 actuations in each nostril | Drug | Sterile water TI-005 protocol |
Primary outcome
Reduction in Headache Intensity
Time frame: 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)
5 secondary outcomes
Reduction in Headache Intensity
Time frame: ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Average Headache Intensity
Time frame: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Presence of 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
Intake of Rescue Medication
Time frame: Up to 24 hours after intervention administration
Participant Satisfaction
Time frame: Up to 24 hours after intervention administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Egilius LH Spierings, MD, PhD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syntocinon and Sterile water in people with Chronic Daily Headache, run by MedVadis Research Corporation at 1 site in United States.
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 4 inclusion and 16 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Headache Intensity (time frame: 2 hours after administration of study medication). 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 15 Jun 2023.