Migraine DisordersPhase 1NCT00604812
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
A Phase 1 study testing rizatriptan benzoate (5 mg) and rizatriptan benzoate (10 mg) in people with Migraine Disorders, run by Organon and Co.
Trial summary
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines. After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- rizatriptan benzoate (5 mg) and rizatriptan benzoate (10 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2007to 17 Sep 2010
- Phase
- Phase 1
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
- Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines
- Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration
Who cannot join
- Subject has no history of migraine headaches
- Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)
- Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Single-Dose Pharmacokinetics of MK0462 in Subjects With Migraines Aged 6 to 17 Years
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.
After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.
- Conditions
- Migraine Disorders
- Being tested
- rizatriptan benzoate (5 mg), rizatriptan benzoate (10 mg), Rizatriptan 5 mg Placebo, Rizatriptan 10 mg Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rizatriptan benzoate (5 mg)Drug
Also called MAXALT®, MK0462
A single dose of rizatriptan 5 mg administered on Day 1.
rizatriptan benzoate (10 mg)Drug
Also called MAXALT®, MK0462
A single dose of rizatriptan 10 mg administered on Day 1.
Rizatriptan 5 mg PlaceboDrug
A single dose of rizatriptan 5 mg placebo administered on Day 1.
Rizatriptan 10 mg PlaceboDrug
A single dose of rizatriptan 10 mg placebo administered on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Panel A Rizatriptan | Experimental | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A. Receives: Drug: rizatriptan benzoate (5 mg) |
| Panel A Placebo | Placebo comparator | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A. Receives: Drug: Rizatriptan 5 mg Placebo |
| Panel B Rizatriptan | Experimental | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B. Receives: Drug: rizatriptan benzoate (10 mg) |
| Panel B Placebo | Placebo comparator | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B. Receives: Drug: Rizatriptan 10 mg Placebo |
| Panel C Rizatriptan | Experimental | Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. Receives: Drug: rizatriptan benzoate (5 mg); Drug: rizatriptan benzoate (10 mg) |
| Panel C Placebo | Placebo comparator | Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. Receives: Drug: Rizatriptan 5 mg Placebo; Drug: Rizatriptan 10 mg Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)
Measured: 24 Hours
Secondary outcomes (4)
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))
Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot
Measured: 24 Hours
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)
Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved
Measured: 24 Hours
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)
Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration
Measured: 24 Hours
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)
Preliminary pharmacokinetics data; Apparent half-life (t½)
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study start17 Dec 2007
- Primary completion17 Sep 2010
- Study completion17 Sep 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604812
- Sponsor's protocol ID
- 0462-083
- Other IDs
- 2007_601
- Status last verified
- Feb 2022
- First submitted
- 17 Oct 2007
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P. Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study. Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30.
PubMed 22289113
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Single-Dose Pharmacokinetics of MK0462 in Subjects With Migraines Aged 6 to 17 Years
- ClinicalTrials.gov ID
- NCT00604812
- Acronym / sponsor ID
- 0462-083
- Conditions
- Migraine Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2007 (actual)
- Primary completion
- 17 Sep 2010 (actual)
- Study completion
- 17 Sep 2010 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 2 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.
After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Panel A Rizatriptan | Experimental | Drug: rizatriptan benzoate (5 mg)Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
| Panel A Placebo | Placebo comparator | Drug: Rizatriptan 5 mg PlaceboSubjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
| Panel B Rizatriptan | Experimental | Drug: rizatriptan benzoate (10 mg)Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
| Panel B Placebo | Placebo comparator | Drug: Rizatriptan 10 mg PlaceboSubjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
| Panel C Rizatriptan | Experimental | Drug: rizatriptan benzoate (5 mg), Drug: rizatriptan benzoate (10 mg)Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. |
| Panel C Placebo | Placebo comparator | Drug: Rizatriptan 5 mg Placebo, Drug: Rizatriptan 10 mg PlaceboSubjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
- Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines
- Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration
Key exclusion criteria (3 listed)
- Subject has no history of migraine headaches
- Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)
- Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study
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 |
|---|---|---|
| rizatriptan benzoate (5 mg)Also: MAXALT®, MK0462A single dose of rizatriptan 5 mg administered on Day 1. | Drug | Panel A Rizatriptan, Panel C Rizatriptan |
| rizatriptan benzoate (10 mg)Also: MAXALT®, MK0462A single dose of rizatriptan 10 mg administered on Day 1. | Drug | Panel B Rizatriptan, Panel C Rizatriptan |
| Rizatriptan 5 mg PlaceboA single dose of rizatriptan 5 mg placebo administered on Day 1. | Drug | Panel A Placebo, Panel C Placebo |
| Rizatriptan 10 mg PlaceboA single dose of rizatriptan 10 mg placebo administered on Day 1. | Drug | Panel B Placebo, Panel C Placebo |
Primary outcome
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
Time frame: 24 Hours
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)
4 secondary outcomes
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))
Time frame: 24 Hours
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)
Time frame: 24 Hours
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)
Time frame: 24 Hours
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)
Time frame: 24 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22289113Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P. Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study. Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30.
- Individual participant dataSharing planned: No
Related trials for Migraine Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rizatriptan benzoate (5 mg) and rizatriptan benzoate (10 mg) in people with Migraine Disorders, run by Organon and Co.
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 3 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 2 Sep 2009). 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?
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs (time frame: 24 Hours). 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 NCT00604812, which also lists 1 linked publication.
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 19 Apr 2024.