MigrainePhase 3CHAMPNCT01581281
The Childhood and Adolescent Migraine Prevention Study
A Phase 3 study testing Amitriptyline and Topiramate in people with Migraine and Migraine Disorders, run by Children's Hospital Medical Center, Cincinnati at 35 sites in United States.
Trial summary
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Migraine, Migraine Disorders, Headache
- What is being tested?
- Amitriptyline and Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 488 participants
- Where
- 35 sitesUnited States
- Study dates
- Jun 2012to Jan 2016
- Phase
- Phase 3
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Migraine with or without aura (International Classification of Headache Disorders, 2nd Edition (ICHD-II) or chronic migraine (ICHD-II revised)
- Migraine frequency based upon prospective headache diary of 28 days must be ≥ 4. Migraine frequency defined as any migraine during one day in the 28 day baseline period (1)
- PedMIDAS Disability Score > 10, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy
- Females or males 8-17 years, inclusive
- Migraine frequency is defined as the period from the onset to the stop time of painful migraine symptoms not to exceed 24 hours with the clock starting at midnight. If painful symptoms last longer than 24 hours, this is considered a new and distinct migraine headache. If painful symptoms recur within 24 hours of initial onset, this is considered part of the initial migraine episode and would be counted as one migraine.
Who cannot join
- Continuous migraine defined as an unrelenting headache for a 28 day period
- Weight less than 30 kg or greater than 120 kg
- Unwilling to avoid taking non-specific acute medication such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications such as triptans more than 6 times per month
- Currently taking other prophylactic anti-migraine medication within a period equivalent to 2 weeks of that medication before entering the screening phase, or the use of Botulinum toxin (Botox®) within 3 months of entering the screening phase
- Subjects who have previously failed an adequate trial of AMI or TPM for prophylaxis of at least 3 months duration at doses recommended for migraine relief because of lack of efficacy or adverse events(2)
- Current use of disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals, SSRIs, or SSNRIs
Show all 17Show fewer
- Known history of allergic reaction or anaphylaxis to AMI or TPM
- Abnormal findings on ECG at baseline, particularly lengthening of the QT interval greater than or equal to 450 msec
- Subject is pregnant or has a positive pregnancy test
- Subject is sexually active and not using a medically acceptable form of contraception
- Diagnosis of epilepsy or other neurological diseases
- History of kidney stones
- Inability to swallow pills after using behavioral techniques if indicated between screening visit and baseline visit (3)
- Present psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) that, in the opinion of the site investigator, would interfere with adherence to study requirements or safe participation in the trial
- Any and all other diagnoses or conditions which in the opinion of the site investigator, that would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study subject
- (2)"Previously failed an adequate trial of AMI or TPM" is defined as: dosage of 1mg/kg/day of AMI or 2 mg/kg/day of TPM; trial of at least 3 months duration; efficacy of having at least a 50% decrease in migraine frequency in response to drug therapy; or unable to tolerate taking the medication due to treatment-related side effects.
- (3)Subjects who cannot swallow pills at the time of the screening visit will be given a training session using behavioral techniques. Upon return for baseline visit, if the subject continues to be unable to swallow pills, the subject will be excluded from the study.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Akron Children's Hospital
Akron, Ohio, 44308
Dent Neurological Institute
Amherst, New York, 14226
Atlanta Headache Specialists
Atlanta, Georgia, 30342
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
The Children's Hospital, Cleveland Clinic
Cleveland, Ohio, 44195
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Nationwide Children's Hospital
Columbus, Ohio, 43205
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230
Josephson Wallack Munshower Neurology Research
Indianapolis, Indiana, 46237
Children's Mercy Hospital
Kansas City, Kansas, 66160
University of Louisville Health Sciences Center
Louisville, Kentucky, 40292
Marshfield Clinic
Marshfield, Wisconsin, 54449
LeBonheur Children's Hospital
Memphis, Tennessee, 38105
Winthrop University Hospital
Mineola, New York, 11501
The Headache Institute at Roosevelt Hospital
New York, New York, 10019
Eastern Virginia Medical School
Norfolk, Virginia, 23510
Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Medical Group
Phoenix, Arizona, 85016
Preferred Clinical Research
Pittsburgh, Pennsylvania, 15236
University of Nevada
Reno, Nevada, 89502
Mayo Clinic
Rochester, Minnesota, 55905
Primary Children's Medical Center
Salt Lake City, Utah, 84108
University of California-San Francisco Headache Center
San Francisco, California, 94115
Schenectady Neurological Constultants, PC
Schenectady, New York, 12308
Seattle Children's Hospital
Seattle, Washington, 98105
Saint Louis University
St Louis, Missouri, 63104
Stanford Hospital and Clinics
Stanford, California, 94305
Scott and White Healthcare
Temple, Texas, 76508
Children's Hospital of Boston
Waltham, Massachusetts, 02453
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Premiere Research Institute
West Palm Beach, Florida, 33407
New England Regional Headache Center
Worcester, Massachusetts, 01605
About this study
Official title: Amitriptyline and Topiramate in the Prevention of Childhood Migraine
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.
Read the detailed description
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents. The investigators want to see if amitriptyline and/or topiramate are better than placebo (sugar pill) in reducing headache frequency in children and adolescents ages 8 to 17 with migraines. At this time, there are no FDA approved medicines approved in the US for the prevention treatment of migraine headaches in children and adolescents.
- Conditions
- Migraine, Migraine Disorders, Headache
- Being tested
- Amitriptyline, Topiramate, Placebo
- Keywords
- Pediatric, Children, Adolescent, Headache, Migraine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Amitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based.
TopiramateDrug
Topiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based.
PlaceboDrug
Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline | Active comparator | Drug to be administered twice daily. Receives: Drug: Amitriptyline |
| Topiramate | Active comparator | Drug to be administered twice daily. Receives: Drug: Topiramate |
| Placebo | Placebo comparator | To be administered twice daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days
The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight.
For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups.
Measured: 4 week baseline period and last 4 weeks of the 24-week trial
Secondary outcomes (4)
Change in Absolute Headache Disability Score on PedMIDAS
The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for:
- Amitriptyline vs. Placebo
- Topiramate vs. Placebo
- Amitriptyline vs Topiramate
Measured: baseline and 24 week endpoint
Change in Number of Headache Days
This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between:
- Amitriptyline vs. placebo
- Topiramate vs. placebo
- Amitriptyline vs. Topiramate
Measured: 4 week baseline period and last 4 weeks of the 24-week trial
Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase
To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups.
Measured: 24 weeks
Occurrence of Treatment Emergent Serious Adverse Events
To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events.
Measured: 24 weeks of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2015
- Study completionJan 2016
Why it stopped: Interim assessment provided sufficient data to answer study questions
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott W. Powers, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiAndrew D. Hershey, MD, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiChristopher S. Coffey, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581281
- Sponsor's protocol ID
- CIN-001
- Other IDs
- 1U01NS076788-01
- Acronym
- CHAMP
- Status last verified
- Jul 2017
- First submitted
- 16 Dec 2011
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified datasets and associated documentation will be submitted to NINDS for archiving and public access, consistent with current NINDS data sharing policy.
Publications
Reidy BL, Powers SW, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Peugh J, Kabbouche MA, Kacperski J, Hershey AD; CHAMP Investigators. Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial. J Pediatr Psychol. 2022 Apr 8;47(4):376-387. doi: 10.1093/jpepsy/jsab123.
PubMed 34865085Reidy BL, Peugh J, Hershey AD, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Kabbouche MA, Kacperski J, Powers SW. Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial. Cephalalgia. 2022 Jan;42(1):44-52. doi: 10.1177/03331024211033551. Epub 2021 Aug 17.
PubMed 34404270Powers SW, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Hershey AD; CHAMP Investigators. Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017 Jan 12;376(2):115-124. doi: 10.1056/NEJMoa1610384. Epub 2016 Oct 27.
PubMed 27788026Hershey AD, Powers SW, Coffey CS, Eklund DD, Chamberlin LA, Korbee LL; CHAMP Study Group. Childhood and Adolescent Migraine Prevention (CHAMP) study: a double-blinded, placebo-controlled, comparative effectiveness study of amitriptyline, topiramate, and placebo in the prevention of childhood and adolescent migraine. Headache. 2013 May;53(5):799-816. doi: 10.1111/head.12105. Epub 2013 Apr 17.
PubMed 23594025
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amitriptyline and Topiramate in the Prevention of Childhood Migraine
- ClinicalTrials.gov ID
- NCT01581281
- Acronym / sponsor ID
- CHAMP / CIN-001
- Conditions
- Migraine, Migraine Disorders, Headache
- Keywords
- Pediatric, Children, Adolescent, Headache, Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim assessment provided sufficient data to answer study questions
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.
Detailed description
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents. The investigators want to see if amitriptyline and/or topiramate are better than placebo (sugar pill) in reducing headache frequency in children and adolescents ages 8 to 17 with migraines. At this time, there are no FDA approved medicines approved in the US for the prevention treatment of migraine headaches in children and adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline | Active comparator | Drug: AmitriptylineDrug to be administered twice daily. |
| Topiramate | Active comparator | Drug: TopiramateDrug to be administered twice daily. |
| Placebo | Placebo comparator | Drug: PlaceboTo be administered twice daily. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Migraine with or without aura (International Classification of Headache Disorders, 2nd Edition (ICHD-II) or chronic migraine (ICHD-II revised)
- Migraine frequency based upon prospective headache diary of 28 days must be ≥ 4. Migraine frequency defined as any migraine during one day in the 28 day baseline period (1)
- PedMIDAS Disability Score > 10, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy
- Females or males 8-17 years, inclusive
Key exclusion criteria (17 listed)
- Continuous migraine defined as an unrelenting headache for a 28 day period
- Weight less than 30 kg or greater than 120 kg
- Unwilling to avoid taking non-specific acute medication such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications such as triptans more than 6 times per month
- Currently taking other prophylactic anti-migraine medication within a period equivalent to 2 weeks of that medication before entering the screening phase, or the use of Botulinum toxin (Botox®) within 3 months of entering the screening phase
- Subjects who have previously failed an adequate trial of AMI or TPM for prophylaxis of at least 3 months duration at doses recommended for migraine relief because of lack of efficacy or adverse events(2)
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 |
|---|---|---|
| AmitriptylineAmitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based. | Drug | Amitriptyline |
| TopiramateTopiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based. | Drug | Topiramate |
| PlaceboPlacebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period. | Drug | Placebo |
Primary outcome
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days
Time frame: 4 week baseline period and last 4 weeks of the 24-week trial
The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight. For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups.
4 secondary outcomes
Change in Absolute Headache Disability Score on PedMIDAS
Time frame: baseline and 24 week endpoint
Change in Number of Headache Days
Time frame: 4 week baseline period and last 4 weeks of the 24-week trial
Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase
Time frame: 24 weeks
Occurrence of Treatment Emergent Serious Adverse Events
Time frame: 24 weeks of the trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34865085Reidy BL, Powers SW, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Peugh J, Kabbouche MA, Kacperski J, Hershey AD; CHAMP Investigators. Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial. J Pediatr Psychol. 2022 Apr 8;47(4):376-387. doi: 10.1093/jpepsy/jsab123.
- Derived from this study: PubMed 34404270Reidy BL, Peugh J, Hershey AD, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Kabbouche MA, Kacperski J, Powers SW. Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial. Cephalalgia. 2022 Jan;42(1):44-52. doi: 10.1177/03331024211033551. Epub 2021 Aug 17.
- Derived from this study: PubMed 27788026Powers SW, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Hershey AD; CHAMP Investigators. Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017 Jan 12;376(2):115-124. doi: 10.1056/NEJMoa1610384. Epub 2016 Oct 27.
- Derived from this study: PubMed 23594025Hershey AD, Powers SW, Coffey CS, Eklund DD, Chamberlin LA, Korbee LL; CHAMP Study Group. Childhood and Adolescent Migraine Prevention (CHAMP) study: a double-blinded, placebo-controlled, comparative effectiveness study of amitriptyline, topiramate, and placebo in the prevention of childhood and adolescent migraine. Headache. 2013 May;53(5):799-816. doi: 10.1111/head.12105. Epub 2013 Apr 17.
- Individual participant dataSharing planned: Yes. De-identified datasets and associated documentation will be submitted to NINDS for archiving and public access, consistent with current NINDS data sharing policy.
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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.
Scott W. Powers, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Andrew D. Hershey, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Christopher S. Coffey, PhD principal investigator
University of Iowa
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amitriptyline and Topiramate in people with Migraine and Migraine Disorders, run by Children's Hospital Medical Center, Cincinnati at 35 sites 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 5 inclusion and 17 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2017). 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?
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days (time frame: 4 week baseline period and last 4 weeks of the 24-week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01581281, which also lists 4 linked publications.
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 10 Aug 2017.