A Study of Prophylaxis for Migraine Patients With Topiramate in India

Migraine Clinical Trial

— PROMPT-IN  

Official title:

Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836874
• Other study ID #: CR100585
• Secondary ID: TOPMATMIG4020
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2013
• Last updated: April 17, 2013
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: April 2013
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: No Health Authority
• Study type: Observational

Clinical Trial 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).

Description:

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites) study. In this study approximately 209 participants will be observed. Participants receiving topiramate will be observed monthly for 3 months. Safety assessments will include evaluation of adverse events and body weight of the participants which will be monitored throughout the study. The total duration of this study will be approximately 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• No intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Up to 3 months	Yes
Primary	Number of adverse events		Up to 3 months	Yes
Primary	Number of participants with incidence of discontinuation of study medication		Up to 3 months	Yes
Primary	Reason for participant's discontinuation of study medication		Up to 3 months	Yes
Primary	Change from baseline in the body weight		Baseline (screening) to 3 months	Yes
Primary	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	Yes
Primary	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	Yes