Trial · NCT00910689
Drug and Non-Drug Treatment Of Severe Migraine
NCT00910689, Phase 4, Completed, Ohio University; results first posted 2009-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug and Non-Drug Treatment Of Severe Migraine. Trials, record NCT00910689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00910689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug and Non-Drug Treatment Of Severe Migraine
- NCT number
- NCT00910689
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 232 participants, actual
- Lead sponsor
- Ohio University
- Conditions
- Migraine Headache
- Interventions
- Propranolol or nadolol, Placebo control, Behavioral Migraine Management (BMM), Optimal Acute Therapy
- First posted
- 2009-06-01
- Last updated
- 2016-11-22
- Results first posted
- 2009-06-01
- Limitations and caveats
- No side effect reached the 5% reporting threshold at either the Month 10 or the Month 16 assessment.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Number of Migraine Episodes Per 30 Days at Month 10. | Change from Month 1 to Month 10 | Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary. |
| Secondary | Change in the Number of Migraine Days Per 30 Days at Month 10 | Change from Month 1 to Month 10 | Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary. |
| Secondary | Change in Quality of Life at Month 10 | Change from Month 1 to Month 10 | Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment. |
| Secondary | Change in Number of Migraine Episodes Per 30 Days at Month 16. | Change from Month 1 to Month 16 | Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary. |
| Secondary | Change in the Number of Migraine Days Per 30 Days at Month 16 | Change form Month 1 to Month 16 | Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary. |
| Secondary | Change in Quality of Life at Month 16 | Change from Month 1 to Month 16 | Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Number of Migraine Episodes Per 30 Days at Month 10. | Change from Month 1 to Month 10 | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Number of Migraine episodes | MEAN |
| SECONDARY | Change in the Number of Migraine Days Per 30 Days at Month 10 | Change from Month 1 to Month 10 | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Number of days | MEAN |
| SECONDARY | Change in Quality of Life at Month 10 | Change from Month 1 to Month 10 | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Scores on a scale | MEAN |
| SECONDARY | Change in Number of Migraine Episodes Per 30 Days at Month 16. | Change from Month 1 to Month 16 | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Number of Migraine Episodes | MEAN |
| SECONDARY | Change in the Number of Migraine Days Per 30 Days at Month 16 | Change form Month 1 to Month 16 | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Number of Days | MEAN |
| SECONDARY | Change in Quality of Life at Month 16 | Change from Month 1 to Month 16 | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Number of Migraine Episodes Per 30 Days at Month 10. | OAT + Placebo (PL) | -2.1 | 95% Confidence Interval -2.2 to -1.9 | Number of Migraine episodes | |
| Change in Number of Migraine Episodes Per 30 Days at Month 10. | OAT + Beta Blocker (Beta-B) | -2.1 | 95% Confidence Interval -2.2 to -1.9 | Number of Migraine episodes | |
| Change in Number of Migraine Episodes Per 30 Days at Month 10. | OAT + BMM + PL | -2.2 | 95% Confidence Interval -2.4 to -2.0 | Number of Migraine episodes | |
| Change in Number of Migraine Episodes Per 30 Days at Month 10. | OAT + BMM + Beta-B | -3.3 | 95% Confidence Interval -3.5 to -3.2 | Number of Migraine episodes | |
| Change in the Number of Migraine Days Per 30 Days at Month 10 | OAT + Placebo (PL) | -3.3 | 95% Confidence Interval -3.6 to -3.0 | Number of days | |
| Change in the Number of Migraine Days Per 30 Days at Month 10 | OAT + Beta Blocker (Beta-B) | -3.9 | 95% Confidence Interval -4.2 to -3.5 | Number of days | |
| Change in the Number of Migraine Days Per 30 Days at Month 10 | OAT + BMM + PL | -3.3 | 95% Confidence Interval -3.7 to -2.9 | Number of days | |
| Change in the Number of Migraine Days Per 30 Days at Month 10 | OAT + BMM + Beta-B | -5.4 | 95% Confidence Interval -5.6 to -5.2 | Number of days | |
| Change in Quality of Life at Month 10 | OAT + Placebo (PL) | -7.1 | 95% Confidence Interval -7.8 to -6.3 | Scores on a scale | |
| Change in Quality of Life at Month 10 | OAT + Beta Blocker (Beta-B) | -7.1 | 95% Confidence Interval -7.7 to -6.6 | Scores on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Month 1: Optimal Acute Therapy Run in | STARTED | OAT + Placebo (PL) | 55 | |
| Month 1: Optimal Acute Therapy Run in | STARTED | OAT + Beta Blocker (Beta-B) | 53 | |
| Month 1: Optimal Acute Therapy Run in | STARTED | OAT + BMM + PL | 55 | |
| Month 1: Optimal Acute Therapy Run in | STARTED | OAT + BMM + Beta-B | 69 | |
| Month 1: Optimal Acute Therapy Run in | COMPLETED | OAT + Placebo (PL) | 53 | |
| Month 1: Optimal Acute Therapy Run in | COMPLETED | OAT + Beta Blocker (Beta-B) | 52 | |
| Month 1: Optimal Acute Therapy Run in | COMPLETED | OAT + BMM + PL | 50 | |
| Month 1: Optimal Acute Therapy Run in | COMPLETED | OAT + BMM + Beta-B | 59 | |
| Month 1: Optimal Acute Therapy Run in | NOT COMPLETED | OAT + Placebo (PL) | 2 | |
| Month 1: Optimal Acute Therapy Run in | NOT COMPLETED | OAT + Beta Blocker (Beta-B) | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | OAT + Placebo (PL) at Month 5 | 3 | 44 | 3 |
| other | Fatigue | General disorders | OAT + Beta-Blocker at Month 5 | 7 | 42 | 7 |
| other | Fatigue | General disorders | OAT + BMM + PL at Month 5 | 2 | 42 | 2 |
| other | Fatigue | General disorders | OAT + BMM + Beta-Blocker at Month 5 | 2 | 48 | 2 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OAT + Placebo (PL) at Month 5 | ||
| Total, all-cause mortality | OAT + Beta-Blocker at Month 5 | ||
| Total, all-cause mortality | OAT + BMM + PL at Month 5 | ||
| Total, all-cause mortality | OAT + BMM + Beta-Blocker at Month 5 | ||
| Total, other adverse events | OAT + Placebo (PL) at Month 5 | 3 | |
| Total, other adverse events | OAT + Beta-Blocker at Month 5 | 7 | |
| Total, other adverse events | OAT + BMM + PL at Month 5 | 2 | |
| Total, other adverse events | OAT + BMM + Beta-Blocker at Month 5 | 2 | |
| Total, serious adverse events | OAT + Placebo (PL) at Month 5 | 0 | 55 |
| Total, serious adverse events | OAT + Beta-Blocker at Month 5 | 0 | 53 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS032374 | DRUG AND NON-DRUG TREATMENT OF SEVERE MIGRAINES | HOLROYD, KENNETH ALLEN | OHIO UNIVERSITY ATHENS | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 1994 to 2004 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00910689
GET https://conductscience.org/api/trials/v1/NCT00910689/results?page=2