Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488839
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2007-06-18
Brief Title:
IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
Sponsor:
Impax Laboratories LLC
Organization:
Impax Laboratories LLC
Study Overview
Official Title:
A Double-Blind Randomized Placebo- and Active Comparator- Controlled Parallel Group Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2017-02
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 purpose of this study is to determine the effects both good and bad of IPX056 on subjects and their spasticity This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity Lastly this study will determine how long IPX056 affects spasticity
Detailed Description:
The primary objective of this study is to demonstrate that IPX056 reduces spasticity measured by Ashworth score in subjects with multiple sclerosis MS This study will also 1 assess the correlation between pharmacokinetic PK and pharmacodynamic PD endpoints Ashworth score and 2 quantify the duration of pharmacodynamic effects for IPX056 as well as marketed baclofen tablet in subjects with Multiple Sclerosis MS after a single dose Additionally the efficacy parameters including Multiple Sclerosis Impact Scale MSIS-29 spasm frequency and nighttime awakening score spasticity control morning stiffness and Global Assessment of Efficacy and Tolerability will be assessed during open-label extension period The safety of IPX056 will be monitored throughout the study
This study consists of 2 parts Part I Screening Visit Visit 1 of the study is a single-dose double-blind randomized placebo- and active comparator-controlled parallel group design containing a single 12 hour PKPD evaluation period Part II is an optional approximately 9-week open-label extension study and will start during Visit 1 immediately after Visit 1 PKPD procedures are completed
This study consists of 2 parts Part I Screening Visit Visit 1 of the study is a single-dose double-blind randomized placebo- and active comparator-controlled parallel group design containing a single 12 hour PKPD evaluation period Part II is an optional approximately 9-week open-label extension study and will start during Visit 1 immediately after Visit 1 PKPD procedures are completed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-000236-16 | EUDRACT_NUMBER | None | None |