Ignite Creation Date:
2024-05-06 @ 9:50 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03093324
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2017-03-16
Brief Title:
A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis RRMS EVOLVE-MS-2
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
The objectives of this study are to evaluate the utility of two gastrointestinal GI symptom scales Individual GI Symptom and Impact Scale IGISIS and Global GI Symptom and Impact Scale GGISIS in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate DMF in Part A to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001294-16 | EUDRACT_NUMBER | None | None |