Trial · NCT00397254
Two Rizatriptan Prescribing Portions for Treatment of Migraine
NCT00397254, Phase 4, Completed, Clinvest; results first posted 2009-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Two Rizatriptan Prescribing Portions for Treatment of Migraine. Trials, record NCT00397254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00397254
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Two Rizatriptan Prescribing Portions for Treatment of Migraine
- NCT number
- NCT00397254
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 197 participants, actual
- Lead sponsor
- Clinvest
- Conditions
- Migraine
- Interventions
- rizatriptan, rizatriptan
- First posted
- 2006-11-09
- Last updated
- 2010-06-08
- Results first posted
- 2009-09-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Days With Migraine | 6 months | |
| Secondary | Number of Migraine Attacks | 6 months | |
| Secondary | Percentage of Responders | 6 months | 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 |
| Secondary | Average Attack Duration | 6 months | |
| Secondary | Headache Severity of All Attacks | 6 months | 4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain) |
| Secondary | Percentage of Attacks With Symptom Elimination at 2 Hours | 6 months | 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 |
| Secondary | Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose | 6 months | 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 |
| Secondary | Adverse Experiences | 6 months | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Days With Migraine | 6 months | 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). | Days | MEAN |
| SECONDARY | Number of Migraine Attacks | 6 months | 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). | Migraine attacks | MEAN |
| SECONDARY | Percentage of Responders | 6 months | 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). | Percentage of Participants | NUMBER |
| SECONDARY | Average Attack Duration | 6 months | 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). | Hours | MEAN |
| SECONDARY | Headache Severity of All Attacks | 6 months | 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). | Units on a scale | MEDIAN |
| SECONDARY | Percentage of Attacks With Symptom Elimination at 2 Hours | 6 months | 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). | Percentage of attacks | NUMBER |
| SECONDARY | Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose | 6 months | 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). | Percentage of attacks | NUMBER |
| SECONDARY | Adverse Experiences | 6 months | 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). | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Days With Migraine | Rizatriptan 27 Tablets - Clinical Limit | 2.666 | Standard Deviation 1.297 | Days | |
| Number of Days With Migraine | Rizatriptan 9 Tablets - Formulary Limit | 2.738 | Standard Deviation 1.313 | Days | |
| Number of Migraine Attacks | Rizatriptan 27 Tablets - Clinical Limit | 4.855 | Standard Deviation 2.093 | Migraine attacks | |
| Number of Migraine Attacks | Rizatriptan 9 Tablets - Formulary Limit | 4.399 | Standard Deviation 1.548 | Migraine attacks | |
| Percentage of Responders | Rizatriptan 27 Tablets - Clinical Limit | 7.79 | Percentage of Participants | ||
| Percentage of Responders | Rizatriptan 9 Tablets - Formulary Limit | 2.70 | Percentage of Participants | ||
| Average Attack Duration | Rizatriptan 27 Tablets - Clinical Limit | 11.569 | Standard Deviation 8.188 | Hours | |
| Average Attack Duration | Rizatriptan 9 Tablets - Formulary Limit | 12.930 | Standard Deviation 9.192 | Hours | |
| Headache Severity of All Attacks | Rizatriptan 27 Tablets - Clinical Limit | 1.50 | Full Range 1.00 to 2.76 | Units on a scale | |
| Headache Severity of All Attacks | Rizatriptan 9 Tablets - Formulary Limit | 1.59 | Full Range 1.00 to 3.00 | Units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rizatriptan 27 Tablets - Clinical Limit | 79 | |
| Overall Study | STARTED | Rizatriptan 9 Tablets - Formulary Limit | 76 | |
| Overall Study | COMPLETED | Rizatriptan 27 Tablets - Clinical Limit | 77 | |
| Overall Study | COMPLETED | Rizatriptan 9 Tablets - Formulary Limit | 74 | |
| Overall Study | NOT COMPLETED | Rizatriptan 27 Tablets - Clinical Limit | 2 | |
| Overall Study | NOT COMPLETED | Rizatriptan 9 Tablets - Formulary Limit | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rizatriptan 27 Tablets - Clinical Limit vs Rizatriptan 9 Tablets - Formulary Limit: Adverse Experiences |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00397254
GET https://conductscience.org/api/trials/v1/NCT00397254/registered