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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00516737
Other study ID # 0462-081
Secondary ID 2007_547
Status Completed
Phase Phase 3
First received
Last updated
Start date October 3, 2007
Est. completion date April 8, 2008

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date April 8, 2008
Est. primary completion date April 8, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Greater than one year history of migraine - Attacks typically mild when they begin and progress to moderate or severe - Experience 1-4 migraine attacks per month Exclusion Criteria: - More than 15 headache days per month - Heart disease - Uncontrolled high blood pressure

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Comparator: rizatriptan benzoate
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Comparator: Placebo
Matching placebo; one dose, treatment of a single migraine attack

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Are Pain Free at 2 Hours Post-Dose Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose. 2 hours post-dose
Secondary Number of Participants With 24-Hour Sustained Pain Freedom 24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary. 24 hours post-dose
Secondary Number of Participants With no Rescue Use up to 24 Hours Post-Dose Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary. 24 hours post-dose
Secondary Number of Participants With Absence of Photophobia at 2 Hours Post-dose Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose. 2 hours post-dose
Secondary Number of Participants With Absence of Phonophobia at 2 Hours Post-dose Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose. 2 hours post-dose
Secondary Number of Participants With Absence of Nausea at 2 Hours Post-dose Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose. 2 hours post-dose
Secondary Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose Level of functional disability was assessed on a paper diary by the participants.
Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.
2 hours post-dose
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