Trial · NCT00772031
NINDS CRC Chronic Migraine Treatment Trial
NCT00772031, Phase 3, Completed, Anne Lindblad; results first posted 2012-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. NINDS CRC Chronic Migraine Treatment Trial. Trials, record NCT00772031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00772031
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NINDS CRC Chronic Migraine Treatment Trial
- NCT number
- NCT00772031
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 191 participants, actual
- Lead sponsor
- Anne Lindblad
- Conditions
- Chronic Migraine
- Interventions
- propranolol LA, topiramate, placebo
- First posted
- 2008-10-15
- Last updated
- 2012-01-24
- Results first posted
- 2012-01-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline | Baseline (pre-randomization), months 5 and 6 post randomization | (Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2). |
| Secondary | Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days | 6 months post randomization | |
| Secondary | Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days | 6 months | |
| Secondary | Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months | Baseline and 6 months | Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21). |
| Secondary | Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months | Baseline and 6 months | MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). |
| Secondary | Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months | baseline and 6 months post randomization | The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study. |
| Secondary | Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months | Baseline and 6 months | The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study. |
| Secondary | Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months | Baseline and 6 Months | The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study. |
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 | Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline | Baseline (pre-randomization), months 5 and 6 post randomization | ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome. | Moderate to severe headache days | MEAN |
| SECONDARY | Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days | 6 months post randomization | All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure | participants | NUMBER |
| SECONDARY | Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days | 6 months | All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months | participants | NUMBER |
| SECONDARY | Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months | Baseline and 6 months | The number who completed the Beck's Depression Inventory at baseline and three months | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months | Baseline and 6 months | per protocol | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months | baseline and 6 months post randomization | per protocol | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months | Baseline and 6 months | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months | Baseline and 6 Months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline | Topiramate Plus Propranolol | 4.4 | Standard Deviation 5.98 | Moderate to severe headache days | |
| Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline | Topiramate Plus Placebo | 4.7 | Standard Deviation 5.66 | Moderate to severe headache days | |
| Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days | Topiramate Plus Proporanolol | 37 | participants | ||
| Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days | Topiramate Plus Placebo | 28 | participants | ||
| Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days | Topiramate Plus Propranolol | 26 | participants | ||
| Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days | Topiramate Plus Placebo | 23 | participants | ||
| Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months | Topiramate Plus Propranolol | 0.3 | Standard Deviation 0.25 | units on a scale | |
| Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months | Topiramate Plus Placebo | 0.6 | Standard Deviation 0.30 | units on a scale | |
| Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months | Topiramate Plus Propranolol | -3.18 | Standard Deviation 3.70 | units on a scale | |
| Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months | Topiramate Plus Placebo | -3.46 | Standard Deviation 3.82 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate Plus Propranolol | 96 | |
| Overall Study | STARTED | Topiramate Plus Placebo | 95 | |
| Overall Study | COMPLETED | Topiramate Plus Propranolol | 64 | |
| Overall Study | COMPLETED | Topiramate Plus Placebo | 52 | |
| Overall Study | NOT COMPLETED | Topiramate Plus Propranolol | 32 | |
| Overall Study | NOT COMPLETED | Topiramate Plus Placebo | 43 |
Source ClinicalTrials.gov
Adverse events46
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 | Dizziness | Nervous system disorders | Topiramate Plus Propranolol | 13 | 96 | |
| other | Dizziness | Nervous system disorders | Topiramate Plus Placebo | 3 | 95 | |
| other | Memory Impairment | Nervous system disorders | Topiramate Plus Propranolol | 6 | 96 | |
| other | Memory Impairment | Nervous system disorders | Topiramate Plus Placebo | 8 | 95 | |
| other | Mental Impairment | Nervous system disorders | Topiramate Plus Propranolol | 12 | 96 | |
| other | Mental Impairment | Nervous system disorders | Topiramate Plus Placebo | 7 | 95 | |
| other | Paraesthesia | Nervous system disorders | Topiramate Plus Propranolol | 12 | 96 | |
| other | Paraesthesia | Nervous system disorders | Topiramate Plus Placebo | 10 | 95 | |
| other | Depression | Psychiatric disorders | Topiramate Plus Propranolol | 8 | 96 | |
| other | Depression | Psychiatric disorders | Topiramate Plus Placebo | 3 | 95 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate Plus Propranolol | ||
| Total, all-cause mortality | Topiramate Plus Placebo | ||
| Total, other adverse events | Topiramate Plus Propranolol | 59 | 96 |
| Total, other adverse events | Topiramate Plus Placebo | 50 | 95 |
| Total, serious adverse events | Topiramate Plus Propranolol | 7 | 96 |
| Total, serious adverse events | Topiramate Plus Placebo | 5 | 95 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topiramate Plus Propranolol vs Topiramate Plus Placebo: Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days | Trial comparisons |
| Topiramate Plus Proporanolol vs Topiramate Plus Placebo: Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days | Trial comparisons |
| Topiramate Plus Propranolol vs Topiramate Plus Placebo: serious adverse events | 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/NCT00772031
GET https://conductscience.org/api/trials/v1/NCT00772031/events?page=2