Adequate Therapy of Topiramate in Migraine
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The objective of this study is to investigate the adequacy of topiramate therapy in prevention of migraine and to compare standard titration therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Disorders |
Drug: Topiramate standard Other: Topiramate and propranolol Other: Topiramate slow titration |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Adequate Therapy of Topiramate in Migraine |
- The frequency of migraine as evaluated through a headache diary completed by the patient [ Time Frame: Between Week 7 and Week 10 ] [ Designated as safety issue: No ]
- The number of migraines occurring [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 245 |
| Study Start Date: | July 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
Topiramate standard Titration period :TPM (Topiramate) initial dose 25mg/d 1 wk upward titration by 25mg/d up to 50-100mg/d. Maintenance period :TPM 50-100mg/d twice a day |
Drug: Topiramate standard
Titration period :TPM (Topiramate) initial dose 25mg/d,1 wk upward titration by 25mg/d up to 50-100mg/d. Maintenance period :TPM 50-100mg/d twice a day |
|
Experimental: 002
Topiramate slow titration Titration period :TPM initial dose 25mg/d 2 wk upward titration by 25mg/d up to 50-100mg/d. Maintenance period :TPM 50-100mg/d twice a day |
Other: Topiramate slow titration
Titration period :TPM initial dose 25mg/d , 2 wk upward titration by 25mg/d up to 50-100mg/d. Maintenance period :TPM 50-100mg/d twice a day |
|
Experimental: 003
Topiramate and propranolol Titration period :TPM initial dose 25mg/d 2 wk upward titration by 25mg/d up to 50-100mg/d. Maintenance period :TPM 50-100mg/d twice a day. PPN (Propranolol) 80mg/d (once or twice a day) |
Other: Topiramate and propranolol
Titration period :TPM initial dose 25mg/d , 2 wk upward titration by 25mg/d up to 50-100mg/d. Maintenance period :TPM 50-100mg/d twice a day. PPN (Propranolol) 80mg/d (once or twice a day) |
Detailed Description:
The objective of this prospective, single-blind, randomized and comparative multi-center study is to investigate the adequacy of topiramate therapy in prevention of migraine and to compare standard titration therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol. The secondary objectives of this clinical study are to examine the change in patient quality of life as measured by the migraine disability assessment (MIDAS) questionnaire and to assess the incidence of adverse events, drug compliance and drug safety. Standard therapy of topiramate 50mg/d will be used as an initial target dose and increased by 25 mg/d in 1-week to a maximum maintenance dose of 100mg/d. Slow therapy of topiramate 50mg/d will be used as an initial target dose and increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d. Slow titration therapy boosted by the concurrent use of propranolol ( propranolol 80mg/d as an initial booster for 6 weeks and topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d) will also be evaluated. Standard therapy: topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 1-week to a maximum maintenance dose of 100mg/d. Slow therapy: topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d. Slow titration therapy and propranolol group: propranolol 80mg/d as an initial booster for 6 weeks and topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The migraine patients who needs the preventive treatment and satisfy all of the following criteria can take part in this study:
Patients who agree to take part in this study
- Patients who have 3-14 episodes of migraine a month
- Patients whose duration of migration is at least six months
- Patients who can read and understand the MIDAS questionnaire
- Female who is using an appropriate contraception method or have negative pregnancy test results
Exclusion Criteria:
- The patients who meet any of the following criteria will be excluded from the study: Patients whose headache attacks at baseline or during the study period are assumed to be caused by a drug withdrawal syndrome
- Patients whose migraine has appeared first at over 50 years of age
- Patients who have taken anticonvulsants (valproic acid, gabapentin), beta adrenergic blockers (propranolol) and calcium antagonists (sibelium, verapamil, diltiazem) within the last eight weeks (drugs for blood pressure control with little relation to migraine including calcium channel blockers [e.g. amlodipine] are allowed)
- Patients who have taken topiramate or propranolol within the last eight weeks
- Patients with progressive neurological disorder
- Patients with severe renal disorder, hepatic failure or diabetes
- Patients whose clinical record is unreliable or incomplete
- Patients who are deemed by investigator's discretion that their participation in the study can threaten their well-being or cause unreliable evaluation results at study completion
- Pregnant or breast-feeding women
- Patients with the history of renal calculus
- Patient with asthma or bradycardia (heart rate < 60 beat/min)
- Patients with severe myofascial pain in craniocervical muscle
- Patient who are participating in another clinical study on a drug which is being developed
Contacts and Locations More Information
No publications provided
| Responsible Party: | Senior Medical director, Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01060111 History of Changes |
| Other Study ID Numbers: | CR011944, MIG-KOR-001 |
| Study First Received: | January 29, 2010 |
| Last Updated: | April 19, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Migraine Topiramate |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Propranolol Topiramate Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents Anticonvulsants Central Nervous System Agents Neuroprotective Agents Protective Agents Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 16, 2013