A clinical trial to study the effects of Almotriptan oral tablets in patients with Migraine Headache

Phase 3

Completed

• Conditions: Health Condition 1: null- Migraine headache

• Registration Number: CTRI/2010/091/001157
• Lead Sponsor: MSN Laboratories Ltd ,115,2 RT (7-1-621/39)2nd Floor, Sanjeeva Reddy Nagar,Hyderabad-500038

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

All subjects with duly filled and signed in ICFs [Informed Consent Forms]

Male and female outpatients ³ 18 years of age.

Diagnosis of migraine, with or without aura

At least moderate pain with migraines

Average of 2 to 6 migraines per month for past 3 months

Duration of headache pain at least 4 hours

Able to tell the difference between a migraine and a tension headache

If taking a medication to prevent migraines, patients must have been taking a maintenance dose for at least 30 days before screening

In generally good health

If female, using birth control

Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.

Exclusion Criteria

Patients unwilling to sign on ICF

Routinely experience other type of headache that might seem like a migraine headache

An average of 15 or more headache days per month in the past 6 months

Migraines began after age 50

Taking 1 medicine for preventing migraines

Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days

Use of non-drug treatment for migraine in past 14 days unless have used this treatment for 14 days and plan to continue throughout study

Overuse of medications that treat pain or nausea

Migraine aura without headache

Hemiplegic or basilar migraines

Usually have vomiting with headache

Headaches that usually occur upon waking

Significant unstable medical disease

Abusing drugs or alcohol

History of a significant mental disorder

Pregnant or breast-feeding

Patients with clinically significant or unstable hepatic, respiratory, or hematologic illnesses, unstable cardiovascular disease, or symptomatic peripheral vascular disease.

Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.

Patients with an estimated creatinine clearance of 60 mL/minute based on serum creatinine levels will be excluded.

Patient?s known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2.

Patients being treated with any of the excluded medications mentioned in the protocol.

Patients with concomitant diseases such as malignancy, HIV

Participation in other trials or Previous participation in this or any other almotriptan clinical trial

Study & Design

• Study Type: Observational
• Study Design: Not specified