A Study of Prophylaxis for Migraine Patients With Topiramate in India

NCT01836874 | Completed

• 2 other identifiers: CR100585TOPMATMIG4020
• Study Type: observational
• Target: 209
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of topiramate in preventing migraine among Indian participants requiring prophylaxis (measure taken to maintain health and prevent the spread of disease).

Conditions

Migraine

Keywords

Migraine; Indian; Topiramate

Outcome Measures

Primary Outcomes (7)

• Number of participants with adverse events

  Up to 3 months

• Number of adverse events

  Up to 3 months

• Number of participants with incidence of discontinuation of study medication

  Up to 3 months

• Reason for participant's discontinuation of study medication

  Up to 3 months

• Change from baseline in the body weight

  Baseline (screening) to 3 months

• Participant's overall assessment of topiramate at the end of the treatment period

  Participant's overall assessment is assessed at the end of study on a 5-point scale wherein 1= Very Good, 2 = Good, 3 = No Change, 4 = Poor \& 5 = Very Poor. Higher scores indicate worsening.

  Month 3

• Physician's overall assessment of topiramate at the end of the treatment period

  Physician's overall assessment is assessed at the end of study on a 5-point scale wherein 1= Very Good, 2 = Good, 3 = No Change, 4 = Poor \& 5 = Very Poor. Higher scores indicate worsening.

  Month 3

Study Arms (1)

Topiramate

Drug: No intervention

Interventions

No intervention DRUG

This is an observational study. Participants receiving topiramate 25 mg once-a-day for 1 week and later on, receiving increase dose up to 200 mg, twice-a-day, orally will be observed for 3 months.

Topiramate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Indian participants experiencing migraine

You may qualify if:

• Participants who experiencing migraine three or more times per month and require prophylaxis medication
• Participants having at least 6 months of migraine history (diagnosed as per international headache society criteria with or without aura)
• Other indications for migraine prophylaxis are: the use of acute treatment medication too frequently (more than 2 treatment days per week); an increasing frequency of headaches that are non-responsive to acute therapy; requiring rescue therapy more than once a month
• Participants who are seen to benefit from topiramate based upon the physician's judgment

You may not qualify if:

• Headaches other than migraine or episodic tension or sinus headaches or having headaches exceeding 15 days per month
• Onset of migraine after age 50
• An exclusively migraine aura without headache or a painful condition other than migraine pain
• Having significant history of unstable medical disease
• At risk in terms of the contraindication in the product insert of topiramate

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 22, 2013
• Study Start: May 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 22, 2013

Record last verified: 2013-04