Phase 4
Completed N=232
Drug and Non-Drug Treatment Of Severe Migraine
Migraine Headache
Source: ClinicalTrials.gov NCT00910689 ↗
Enrolled (actual)
232
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcomePrimary: Change in Number of Migraine Episodes Per 30 Days at Month 10. — -2.1; -2.1; -2.2; -3.3 Number of Migraine episodes — p=< .01
Summary
The purpose of this study is to determine if the addition of preventive medication, behavior migraine management or the combination of preventive medication and behavior migraine management improves the outcome of optimal acute therapy for frequent migraines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Migraine Episodes Per 30 Days at Month 10. |
-2.1; -2.1; -2.2; -3.3 | < .01 sig |
| SECONDARY Change in the Number of Migraine Days Per 30 Days at Month 10 |
-3.3; -3.9; -3.3; -5.4 | < .03 sig |
| SECONDARY Change in Quality of Life at Month 10 |
-7.1; -7.1; -8.6; -13.0 | <.005 sig |
| SECONDARY Change in Number of Migraine Episodes Per 30 Days at Month 16. |
-2.5; -2.5; -2.7; -3.8 | <.001 sig |
| SECONDARY Change in the Number of Migraine Days Per 30 Days at Month 16 |
-3.9; -4.5; -4.1; -6.1 | <.001 sig |
| SECONDARY Change in Quality of Life at Month 16 |
-8.8; -8.5; -9.6; -15.2 | < .001 sig |
Eligibility Criteria
Inclusion Criteria
- 18 to 65 years
- Diagnosis of migraine with or without aura (International Classification of Headache Disorders)
- 3 or more migraine episodes/month with disability for the past 6 months
- Less than 20 total headache days/month for the past 6 months
Exclusion Criteria
- Medication overuse headaches
- Currently taking medications contraindicated by study protocol and unable or unwilling to withdraw
- Concurrently undergoing counseling/psychotherapy treatment
- Unable to read, understand or record information in study diaries, questionnaires, and migraine management manual.
- Unable/unwilling to give written informed consent
- History of exclusionary medical condition such as, but not limited to, epilepsy, heart disease, kidney disease, liver disease, hepatic or renal impairment, stroke, ischemic abdominal syndromes, peripheral vascular disease.
- Uncontrolled hypertension at screening (sitting systolic pressure > 160 mmHg, diastolic pressure > 95 mmHg)
- Fertile female who is breastfeeding, pregnant planning a pregnancy within the next year or is unwilling to use adequate contraception.
- Has exclusionary medical condition such as but not limited to diabetes (insulin dependent), tuberculosis, bronchospastic disease (asthma), heart disease (or multiple risk factors for heart disease), angina pectoris, documented silent ischemia, or cardiac arrythmias requiring medication, or a clinically significant EKG abnormality.
- Other pain diagnosis is primary presenting problem (e.g., fibromyalgia)
- Has a substance abuse problem or a psychological disorder that prevents participation in study (e.g., unmanaged severe depression that requires immediate treatment or limits participation in home-based treatment)
- Hypersensitivity, intolerance or contraindication to use of Propranolol, Nadolol, Sumatriptan, or Rizatriptan
Data sourced from ClinicalTrials.gov (NCT00910689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.