MigrainePROMPT-INNCT01836874
A Study of Prophylaxis for Migraine Patients With Topiramate in India
An observational study of Migraine, run by Janssen-Cilag Ltd..
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- Type of treatment
- Pill or oral medicine
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Indian participants experiencing migraine
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)
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).
Read the detailed 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.
- Conditions
- Migraine
- Being tested
- No intervention
- Keywords
- Migraine, Indian, Topiramate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 3 months
Number of adverse events
Measured: Up to 3 months
Number of participants with incidence of discontinuation of study medication
Measured: Up to 3 months
Reason for participant's discontinuation of study medication
Measured: Up to 3 months
Change from baseline in the body weight
Measured: 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.
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836874
- Sponsor's protocol ID
- CR100585
- Other IDs
- TOPMATMIG4020
- Acronym
- PROMPT-IN
- Status last verified
- Apr 2013
- First submitted
- 21 Mar 2013
- Last updated
- 22 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)
- ClinicalTrials.gov ID
- NCT01836874
- Acronym / sponsor ID
- PROMPT-IN / CR100585
- Conditions
- Migraine
- Keywords
- Migraine, Indian, Topiramate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topiramate | – | Drug: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Indian participants experiencing migraine
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis 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. | Drug | Topiramate |
Primary outcome
Number of participants with adverse events
Time frame: Up to 3 months
Number of adverse events
Time frame: Up to 3 months
Number of participants with incidence of discontinuation of study medication
Time frame: Up to 3 months
Reason for participant's discontinuation of study medication
Time frame: Up to 3 months
Change from baseline in the body weight
Time frame: Baseline (screening) to 3 months
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Janssen-Cilag Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Up to 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.