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Completed

NCT Number: NCT01836874

A Study of Prophylaxis for Migraine Patients With Topiramate in India

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Up to 3 months

  2. Number of adverse events

    Time frame: Up to 3 months

  3. Number of participants with incidence of discontinuation of study medication

    Time frame: Up to 3 months

  4. Reason for participant's discontinuation of study medication

    Time frame: Up to 3 months

  5. Change from baseline in the body weight

    Time frame: Baseline (screening) to 3 months

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

    Time frame: Month 3

    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.

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

    Time frame: Month 3

    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.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.

Industry

Registry information

Official study title

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

Acronym: PROMPT-IN

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 22, 2013
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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