Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748483
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-02-20
Brief Title:
Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Randomized Double-Blind Parallel-Group Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability Safety and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine TEMPLE
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMPLE
Brief Summary:
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing nausea vomiting sensitivity to light and sound or other symptoms The main goal of the study is to evaluate the tolerability how patients handle the study treatment and safety of atogepant compared to topiramate in participants with migraine
Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine 0 to 14 migraine days per month and is being studied for the preventative treatment of migraine globally Topiramate is an approved medication for migraine prevention This study is conducted in 2 periods In Period 1 participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate In Period 2 eligible participants will receive atogepant Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world
Participants will receive atogepant and placebo for topiramate or topiramate and placebo for atogepant for 24 weeks in Period 1 Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth After 24 weeks all eligible participants will receive atogepant for 52 weeks in Period 2 Participants are monitored for safety for 4 weeks after their last study treatment
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The safety and tolerability of the treatment will be checked by medical assessments blood tests checking for adverse events and completing questionnaires
Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine 0 to 14 migraine days per month and is being studied for the preventative treatment of migraine globally Topiramate is an approved medication for migraine prevention This study is conducted in 2 periods In Period 1 participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate In Period 2 eligible participants will receive atogepant Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world
Participants will receive atogepant and placebo for topiramate or topiramate and placebo for atogepant for 24 weeks in Period 1 Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth After 24 weeks all eligible participants will receive atogepant for 52 weeks in Period 2 Participants are monitored for safety for 4 weeks after their last study treatment
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The safety and tolerability of the treatment will be checked by medical assessments blood tests checking for adverse events and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501172-25-00 | OTHER | EU CT | None |