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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


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
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