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Two Rizatriptan Prescribing Portions for Treatment of Migraine

An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00397254
Enrollment
197
Registered
2006-11-09
Start date
2006-12-31
Completion date
2008-01-31
Last updated
2010-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, rizatriptan

Brief summary

The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9 rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.

Detailed description

A common clinical perception exists that less effective treatment of attacks increases the burden of disease across attacks in the form of increased attack frequency, severity, duration, and/or treatability. If this perception is true, more effective treatment decreases the burden of disease across attacks. There are multiple barriers to effective treatment. The triptan class of migraine medications is frequently dispensed in the context of health benefit plan formulary limitations. Because of limited supply, medications must be used very cautiously. Patients may hoard medication in reaction to fear of running out. Overly cautious use and hoarding may lead to greater disease burden. The purpose of this study is to compare the effect of two allocations of rizatriptan - a more limited allocation (Formulary Limit) vs. a less limited allocation (Clinical Limit) on disease burden.

Interventions

DRUGrizatriptan

10mg ODT 27 tablets

Sponsors

Clinvest
Lead SponsorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patient is at least 18 years of age * Patient has at least a 1-year history of migraine with or without aura by International Headache Society (IHS) criteria 1.1 and 1.2 * Patient typically has 3-8 migraine attacks/month * Patient has less than 10 headache days/month with no evidence of IHS 8.2 Medication Overuse Headache * Patient receives their triptan medication under a pre-determined prescribing allocation ranging from 6-12 tablets per month for the last 3 months preceding Visit 1. * Patient and investigator agree that multiple doses of rizatriptan described in the package circular are appropriate for non-responsive or recurring headache. * Patient uses a triptan as mainstay of acute therapy at Visit 1. * Patient of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of rizatriptan outside the study. * Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.

Exclusion criteria

* Patient has headache disorders beyond migraine or episodic tension-type headache IHS 2.1 * Patient is receiving prophylactic therapy for migraine * Patient is currently taking: Daily or nearly daily (typically \>3 days out of 7 days) use of non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, or other analgesics. Aspirin less than or equal to 325mg daily is allowed for cardioprotection. Monoamine oxidase inhibitors (MAOIs) Propranolol Patient taking either an MAOI ro propranolol may be enrolled in the study, if in the clinical judgement of the investigator, either of these medications can be discontinued 2 weeks prior to study entry. Otherwise the use of MAOIs and propranolol are prohibited during the study. * Patient has basilar or hemiplegic migraine headache. * Patient has history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or finding consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease. * Patient has uncontrolled hypertension. * Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan or any of its inactive ingredients. * Patient is pregnant or a nursing mother. * Patient has a history (within 1 year) or current evidence of drug or alcohol abuse. * Patient has received treatment with an investigational device or compound within 30 days of the study (Visit 1). * Patient had clinical evidence of significant pulmonary, renal, hepatic, endocrine, neurologic (apart from migraine), psychiatric or any other condition that, in the opinion of the investigator may confound the results of the study, pose an additional risk, or interfere with optimal participation in the study.

Design outcomes

Primary

MeasureTime frame
Number of Days With Migraine6 months

Secondary

MeasureTime frameDescription
Percentage of Responders6 monthsPercentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group
Average Attack Duration6 months—
Headache Severity of All Attacks6 months4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)
Number of Migraine Attacks6 months—
Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose6 monthsPercentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group
Adverse Experiences6 monthsParticipants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.
Percentage of Attacks With Symptom Elimination at 2 Hours6 monthsPercentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group

Countries

United States

Participant flow

Pre-assignment details

3-month Baseline Period occurred prior to randomization to Clinical Limit or Formulary Limit groups. 42 subjects discontinued from total enrollment of 197: (2) Adverse Event (AE), (10) Lost to Follow Up (LFU), (11) Withdrew consent, (1) Pregnancy, (16) Failed to meet Inclusion/Exclusion at Visit 4 Randomization, (2) Other

Participants by arm

ArmCount
Baseline Period - Rizatriptan 9 Tablets
Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.
197
Total197

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22

Baseline characteristics

CharacteristicBaseline Period - Rizatriptan 9 Tablets
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
197 Participants
Age Continuous42 years
Region of Enrollment
United States
197 participants
Sex: Female, Male
Female
173 Participants
Sex: Female, Male
Male
24 Participants

Outcome results

Primary

Number of Days With Migraine

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (MEAN)Dispersion
Rizatriptan 27 Tablets - Clinical LimitNumber of Days With Migraine2.666 DaysStandard Deviation 1.297
Rizatriptan 9 Tablets - Formulary LimitNumber of Days With Migraine2.738 DaysStandard Deviation 1.313
Secondary

Adverse Experiences

Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (NUMBER)
Rizatriptan 27 Tablets - Clinical LimitAdverse Experiences18 Participants
Rizatriptan 9 Tablets - Formulary LimitAdverse Experiences24 Participants
Secondary

Average Attack Duration

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (MEAN)Dispersion
Rizatriptan 27 Tablets - Clinical LimitAverage Attack Duration11.569 HoursStandard Deviation 8.188
Rizatriptan 9 Tablets - Formulary LimitAverage Attack Duration12.930 HoursStandard Deviation 9.192
Secondary

Headache Severity of All Attacks

4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (MEDIAN)
Rizatriptan 27 Tablets - Clinical LimitHeadache Severity of All Attacks1.50 Units on a scale
Rizatriptan 9 Tablets - Formulary LimitHeadache Severity of All Attacks1.59 Units on a scale
Secondary

Number of Migraine Attacks

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (MEAN)Dispersion
Rizatriptan 27 Tablets - Clinical LimitNumber of Migraine Attacks4.855 Migraine attacksStandard Deviation 2.093
Rizatriptan 9 Tablets - Formulary LimitNumber of Migraine Attacks4.399 Migraine attacksStandard Deviation 1.548
Secondary

Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose

Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (NUMBER)
Rizatriptan 27 Tablets - Clinical LimitPercentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose50.74 Percentage of attacks
Rizatriptan 9 Tablets - Formulary LimitPercentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose48.67 Percentage of attacks
Secondary

Percentage of Attacks With Symptom Elimination at 2 Hours

Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (NUMBER)
Rizatriptan 27 Tablets - Clinical LimitPercentage of Attacks With Symptom Elimination at 2 Hours58.35 Percentage of attacks
Rizatriptan 9 Tablets - Formulary LimitPercentage of Attacks With Symptom Elimination at 2 Hours56.60 Percentage of attacks
Secondary

Percentage of Responders

Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group

Time frame: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

ArmMeasureValue (NUMBER)
Rizatriptan 27 Tablets - Clinical LimitPercentage of Responders7.79 Percentage of Participants
Rizatriptan 9 Tablets - Formulary LimitPercentage of Responders2.70 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026