Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00637286
Other study ID # D1223C00002
Secondary ID
Status Completed
Phase Phase 4
First received February 8, 2008
Last updated April 3, 2009
Start date July 2004
Est. completion date May 2005

Study information

Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMTā„¢ (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in treating migraine over a period of 6 months


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Have an established diagnose of migraine as with an age at onset of less than 50 years

- Have experienced an average of at least 1 migraine headache per month in the previous three months

- Be able to differentiate between migraine and non-migraine headaches

Exclusion Criteria:

- Use of any triptan within the last 12 months or use of MAO-A inhibitors, methysergide or methylergonovine in the 2 weeks before entering the study.

- History of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache

- History, symptoms, or significant risk factors for ischaemic heart or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways or arrhythmias or uncontrolled hypertension.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Zolmitriptan
5mg Nasal Spray

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Migraine Disability Assessment questionnaire (MIDAS) score Twice within 28 weeks No
Secondary Explore patients assessment of value of zolmitriptan Maximum of 3 times between 1 - 28 weeks No
See also
  Status Clinical Trial Phase
Completed NCT05525611 - Cabergoline as a Preventive Treatment for Chronic Migraine N/A
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Recruiting NCT03832998 - Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine Phase 3
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Completed NCT06304675 - Manageable Environmental Factors in Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Completed NCT04179474 - Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine Phase 1
Recruiting NCT04603976 - Registry for Migraine - Clinical Core Phase 4
Completed NCT03597529 - CHOCOlate MeLatonin for AdolescenT MigrainE Phase 2
Completed NCT04197349 - Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman Phase 1
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Active, not recruiting NCT05064371 - Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan Phase 3
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Not yet recruiting NCT04859374 - Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach N/A
Not yet recruiting NCT03083860 - Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions. N/A
Completed NCT02905227 - A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder Phase 1
Enrolling by invitation NCT02532023 - The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients Phase 4
Completed NCT02108678 - One-Day Intervention for Depression and Impairment in Migraine Patients N/A