Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625060
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicentre Randomised Double-blind Placebo-controlled Dose Escalation and Dose Finding Phase II Study to Evaluate the Safety and Efficacy of IPN10200 in the Prevention of Episodic or Chronic Migraine in Adults
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MERANTI
Brief Summary:
A migraine is a headache with severe throbbing pain or a pulsating sensation usually on one side of the head It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound Migraines are caused by a series of events when the brain gets stimulated or activated which causes the release of chemicals that cause pain IPN10200 is a medication that stops the release of these chemical messengers
Participants with episodic migraine EM or chronic migraine CM will be included in both Step 1 and Step 2 Headache days are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms Migraine days occur when the headache displays clear migraine characteristics
This study aims to determine
The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM
The right amount dose of IPN10200 to inject at each point
The total amount dose of IPN10200 that provides the best balance between safety and efficacy preventing migraines
Participants will need to complete a daily electronic migraine Diary eDiary and questionnaires throughout the study The total study duration for a participant will be up to 44 weeks
Participants with episodic migraine EM or chronic migraine CM will be included in both Step 1 and Step 2 Headache days are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms Migraine days occur when the headache displays clear migraine characteristics
This study aims to determine
The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM
The right amount dose of IPN10200 to inject at each point
The total amount dose of IPN10200 that provides the best balance between safety and efficacy preventing migraines
Participants will need to complete a daily electronic migraine Diary eDiary and questionnaires throughout the study The total study duration for a participant will be up to 44 weeks
Detailed Description:
The study will consist of 3 periods
1 A screening period to assess whether the participant can take part in the study
2 Step 1 is divided in two cohorts The study will assess sequentially the safety of two doses of IPN10200 a lower dose in the cohort 1 and a higher dose in cohort 2 Participants will be administered with the study drug or placebo The treatment is injected in muscles of the head face and neck The safety of participants is monitored throughout the 36 weeks at each cohort
3 Step 2 In this step new eligible participants will be divided into two groups based on their diagnosis EM or CM These groups will then be randomly assigned to one of three intervention groups Dose A Dose B or a placebo The intervention will be given in a series of injections in muscles of the head face and neck Participants will be monitored for both efficacy and safety until they complete the Week 36 visit the end of study
1 A screening period to assess whether the participant can take part in the study
2 Step 1 is divided in two cohorts The study will assess sequentially the safety of two doses of IPN10200 a lower dose in the cohort 1 and a higher dose in cohort 2 Participants will be administered with the study drug or placebo The treatment is injected in muscles of the head face and neck The safety of participants is monitored throughout the 36 weeks at each cohort
3 Step 2 In this step new eligible participants will be divided into two groups based on their diagnosis EM or CM These groups will then be randomly assigned to one of three intervention groups Dose A Dose B or a placebo The intervention will be given in a series of injections in muscles of the head face and neck Participants will be monitored for both efficacy and safety until they complete the Week 36 visit the end of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None