Continuous Treatment Study of Topiramate in Migraine Participants
Ключови думи
Резюме
Описание
This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than one center), dose-titration (dose escalation/reduction) study of topiramate in participants with migraine. This study is a continuous study for the participants who were enrolled in the JNS019-JPN-02 study. Participants who completed the JNS019-JPN-02 study will receive treatment for 52 weeks starting at Visit 4 of the JNS019-JPN-02 study. The present study will consist of 3 weeks of Transfer period (during this period the dose titration will take place and along with dose titration the new treatment will be initiated at 25 milligram per day [25mg/day]), Continuous treatment period (32 weeks), Exit period (up to 3 weeks) and Follow-up period (4 weeks). Participants in the Continuous treatment period will receive topiramate tablets orally in the dose range of 50 mg/day to 100 mg/day. Dose can be increased or decreased as per Investigator's discretion. The maximum daily dose will be 200 mg/day. Efficacy will be primarily evaluated by change from Baseline in the number of monthly migraine attacks in Continuous treatment period. Participants' safety will be monitored throughout the study.
Дати
Последна проверка: | 04/30/2013 |
Първо изпратено: | 02/24/2013 |
Очаквано записване подадено: | 02/25/2013 |
Първо публикувано: | 02/26/2013 |
Изпратена последна актуализация: | 05/23/2013 |
Последна актуализация публикувана: | 05/30/2013 |
Дата на първите подадени резултати: | 03/18/2013 |
Дата на първите подадени резултати от QC: | 03/18/2013 |
Дата на първите публикувани резултати: | 05/05/2013 |
Действителна начална дата на проучването: | 07/31/2007 |
Приблизителна дата на първично завършване: | 10/31/2009 |
Очаквана дата на завършване на проучването: | 10/31/2009 |
Състояние или заболяване
Интервенция / лечение
Drug: Topiramate
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: Topiramate | Drug: Topiramate Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg. |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 20 Years Да се 20 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - Participants who completed the JNS019-JPN-02 study or discontinued the study at Week 4 or after in fixed-dose period because of insufficient efficacy Exclusion Criteria: - Participants who discontinued the JNS019-JPN-02 study for an adverse event unrelated to the underlying disease - Participants judged unfavorable to be transferred to this study because of the safety assessments in the JNS019-JPN-02 study - Pregnant (carrying an unborn baby) female participants - Other participants who were considered ineligible as per Investigator's discretion |
Резултат
Първични изходни мерки
1. Number of Participants With Adverse Events [Baseline up to 28 days after last dose of study drug]
Вторични изходни мерки
1. Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period [Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)]
2. Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period [Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)]
3. Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period [Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)]
4. Change From Baseline in the Average Number of Migraine Attacks According to the Diagnostic Criteria of the International Headache Society Per Month in Continuous Treatment Period [Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)]
5. Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period [Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)]
6. Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period [Baseline (28 days before randomization) and Day 197 to Day 225]
7. Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period [Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)]
8. Percentage of Participants With Response to Treatment [Baseline (28 days before randomization) up to Day 225]
9. Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score [Baseline (28 days before randomization) and FE (Day 225/early discontinuation)]