A Clinical Trial to evaluate efficacy and safety of zolmitriptan 5 mg nasal spray in acute treatment of migraine
- Conditions
- Health Condition 1: null- Migraine
- Registration Number
- CTRI/2009/091/000196
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 126
1. Written, signed, dated and institutional review board (IRB) or independent ethics committee (IEC) approved informed consent obtained from literate subjects before performing any screening procedures.
2. Men & Women age >= 18 to <= 65 years.
3. Established diagnosis of migraine with or without aura as defined by the International Headache Society criteria.
4. History of migraine symptoms for at least 1 year.
5. Age of migraine onset < 50 years.
6. An average of 9 migraine attacks in the previous 3 months prior to screening.
7. Subject able to distinguish between migraine and non migraine headaches.
8. Subject able to follow study procedures.
1.History of basilar, opthalmoplegic or hemiplegic migraine, known resistance to treatment with triptans or atypical migraine.
2.Any potentially serious neurological condition associated with headache or any other existing clinically significant neurological disease.
3.Experience of non-migraine headache on 10 days per month in the previous 6 months.
4.Use of a non-stable dose of a migraine prophylactic agent 2 months prior to screening.
5.Uncontrolled Hypertension (systolic >=150 or diastolic >= 95 mm of Hg).
6.History, symptoms or signs of cerebrovascular accidents (CVA) or strokes of any type or transient ischaemic attacks or any other significant cerebrovascular disease.
7.History, symptoms or signs of peripheral vascular disease, symptoms suggestive of disease of the nasopharyngeal system e.g. allergic rhinitis, common cold etc.
8.Clinically significant ECG, Laboratory values, as judged by the investigator.
9.History of alcohol or drug abuse or dependence.
10. Participation in an investigational study within 30 days prior to screening.
11.Female who is pregnant or lactacting or planning to be pregnant.
12.Known hypersensitivity or intolerable adverse reaction to zolmitriptan or other 5HT IB/ID receptor agonist or to any components of the study medications.
13. Existing clinically significant systemic, renal, hepatic, gastrointestinal, endocrine, respiratory or psychiatric disease.
14. Women of child bearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator.
15.Use of monoamine oxidase inhibitors, selective serotonin reuptake inhibitor, methysergide, methylergonovine and medications from alternative system of medicine within 2 weeks prior to screening.
16. History, symptoms or signs of ischemic heart disease including angina pectoris of any type, Prinzmetalâ??s variant angina or coronary vasospasm, all forms of myocardial infarction, silent myocardial ischemia, arrhythmias or cardiac accessory pathway disorders e.g. Wolf Parkinson White syndrome or any other significant cardiovascular disease or significant risk factors for cardiovascular disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Headache response at 2 hours after treatment with study drug.Timepoint: Between Zolmitriptan and Placebo Group
- Secondary Outcome Measures
Name Time Method ? Pain free at 4 hrs, 2 hrs, 1 hr, 30 mins and 15 minsTimepoint: Between Zolmitriptan and Placebo Group;? Return to normal activities at 4 hrs, 2 hrs, 1 hr, 30 mins and 15 mins.Timepoint: Between Zolmitriptan and Placebo Group;? Sustained headache response at 24 hrsTimepoint: Between Zolmitriptan and Placebo Group;? Use of rescue medicationTimepoint: Between Zolmitriptan and Placebo Group;?Resolution of non-headache symptomsTimepoint: Between Zolmitriptan and Placebo Group;?Sustained pain free at 24 hrsTimepoint: Between Zolmitriptan and Placebo Group;Headache recurrenceTimepoint: Between Zolmitriptan and Placebo Group;Headache response at 4 hrs, 1 hr, 30 mins and 15 mins.Timepoint: Between Zolmitriptan and Placebo Group;Subject?s overall satisfaction with treatmentTimepoint: Between Zolmitriptan and Placebo Group;Time to onset of Headache response.Timepoint: Between Zolmitriptan and Placebo Group;Willingness of the subject to use the medication in futureTimepoint: Between Zolmitriptan and Placebo Group