Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03990649
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2019-06-17
Brief Title:
Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome CRPS
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Takeda
Study Overview
Official Title:
A Phase 2a Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy Safety and Tolerability of TAK-935 as an Adjunctive Therapy in Adult Subjects With Chronic Complex Regional Pain Syndrome
Status:
COMPLETED
Status Verified Date:
2021-06
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 investigate the effect of soticlestat TAK-935 on calculated 24-hour average pain intensity by the numeric pain scale NPS
Detailed Description:
The drug being tested in this study is called soticlestat TAK-935 Soticlestat is being tested to treat people with chronic complex regional pain syndrome CRPS This study will look at the efficacy safety and tolerability of soticlestat as an adjunctive therapy in participants with CRPS
The study will enroll approximately 24 patients Participants will be randomly assigned by chance like flipping a coin in 21 ratio to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
Soticlestat 100 mg tablets 100 200 or 300 mg twice daily BID Placebo dummy inactive pill - this is a tablet that looks like the study drug but has no active ingredient
Participants will receive 100 mg soticlestat tablets or soticlestat matching placebo tablets BID for Week 1 2x100 mg soticlestat tablets or soticlestat matching placebo tablets BID for Week 2 and followed by 3x100 mg soticlestat tablets or soticlestat matching placebo tablets BID for Week 3 Dose will be uptitrated based on safety and tolerability in titration period Participants will continue to receive the same dose in maintenance period Dose adjustments during maintenance period may take place due to safety and tolerability
Participants will then enter Part B optional or taper period In Part B all participants will receive soticlestat 2x100 mg tablets BID for 1 Week followed by soticlestat 3x100 mg tablets BID for 1 Week Dose will be uptitrateddowntitrated based on safety and tolerability in titration period Part B participants will continue to receive the same dose in maintenance period Part B and followed by a taper period
This multi-center trial will be conducted in United Kingdom The overall time to participate in this study is approximately 36 weeks Participants will make multiple visits to the clinic and will be contacted by telephone 15 days after last dose of study drug for a follow-up assessment
The study will enroll approximately 24 patients Participants will be randomly assigned by chance like flipping a coin in 21 ratio to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
Soticlestat 100 mg tablets 100 200 or 300 mg twice daily BID Placebo dummy inactive pill - this is a tablet that looks like the study drug but has no active ingredient
Participants will receive 100 mg soticlestat tablets or soticlestat matching placebo tablets BID for Week 1 2x100 mg soticlestat tablets or soticlestat matching placebo tablets BID for Week 2 and followed by 3x100 mg soticlestat tablets or soticlestat matching placebo tablets BID for Week 3 Dose will be uptitrated based on safety and tolerability in titration period Participants will continue to receive the same dose in maintenance period Dose adjustments during maintenance period may take place due to safety and tolerability
Participants will then enter Part B optional or taper period In Part B all participants will receive soticlestat 2x100 mg tablets BID for 1 Week followed by soticlestat 3x100 mg tablets BID for 1 Week Dose will be uptitrateddowntitrated based on safety and tolerability in titration period Part B participants will continue to receive the same dose in maintenance period Part B and followed by a taper period
This multi-center trial will be conducted in United Kingdom The overall time to participate in this study is approximately 36 weeks Participants will make multiple visits to the clinic and will be contacted by telephone 15 days after last dose of study drug for a follow-up assessment
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