Migraine HeadacheNCT00850421
Pilot Study of BOTOX for Migraine Headaches
A study testing Botulinum Toxin Type A in people with Migraine Headache, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purposes of this study are to assess whether subjects treated with BOTOX will: 1. have a decrease in the frequency and intensity of migraine headaches 2. experience improvements in quality of life 3. experience a reduction in the frequency of health care services obtained. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 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
- Subjects > 18 years of age
- Subject has an established history of migraine headache, with or without aura, per IHS criteria (1.2.1 or 1.1), for at least 6 months prior to screening.
- Subject receives primary health care from Park Nicollet Health Services.
Who cannot join
- Subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation.
- Additional eligibility will be discussed at point of contact
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Health Services
Minneapolis, Minnesota, 55426
About this study
Official title: A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches
The purposes of this study are to assess whether subjects treated with BOTOX will:
- have a decrease in the frequency and intensity of migraine headaches
- experience improvements in quality of life
- experience a reduction in the frequency of health care services obtained.
- Conditions
- Migraine Headache
- Being tested
- Botulinum Toxin Type A
- Keywords
- migraine headache, Botulinum Toxin Type A, BOTOX, BTX-A
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called BOTOX
100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A | Other | Not described Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Measured: 190 days
Secondary outcomes (2)
To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Measured: 190 days
To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.
Measured: 190 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startApr 2004
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Recently published BOTOX efficacy data and study design deficits.
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 Migraine 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Frederick Taylor, MD, Principal investigator, Park Nicollet Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850421
- Sponsor's protocol ID
- 01837-04-C
- Status last verified
- Jul 2013
- First submitted
- 23 Feb 2009
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches
- ClinicalTrials.gov ID
- NCT00850421
- Acronym / sponsor ID
- 01837-04-C
- Conditions
- Migraine Headache
- Keywords
- migraine headache, Botulinum Toxin Type A, BOTOX, BTX-A
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recently published BOTOX efficacy data and study design deficits.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Apr 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 18 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to assess whether subjects treated with BOTOX will:
- have a decrease in the frequency and intensity of migraine headaches
- experience improvements in quality of life
- experience a reduction in the frequency of health care services obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A | Other | Drug: Botulinum Toxin Type A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects > 18 years of age
- Subject has an established history of migraine headache, with or without aura, per IHS criteria (1.2.1 or 1.1), for at least 6 months prior to screening.
- Subject receives primary health care from Park Nicollet Health Services.
Key exclusion criteria (2 listed)
- Subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation.
- Additional eligibility will be discussed at point of contact
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: BOTOX100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline) | Drug | Botulinum Toxin Type A |
Primary outcome
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Time frame: 190 days
2 secondary outcomes
To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Time frame: 190 days
To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.
Time frame: 190 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- 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.
Frederick Taylor, MD principal investigator
Park Nicollet Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A in people with Migraine Headache, run by HealthPartners Institute 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Sep 2018. 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. 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 18 Sep 2013). 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?
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. (time frame: 190 days). 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 26 Sep 2018.