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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Migraine

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01836874

CR100585

TOPMATMIG4020 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

209 participants in 1 patient group

Topiramate

Treatment:

Drug: No intervention