Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)

NCT03990649 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TAK-935-2008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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).

Conditions

Complex Regional Pain Syndrome

Keywords

Drug Therapy; Soticlestat; TAk-935

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A

  The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative change from Baseline indicated improvement.

  Baseline and Week 15

Secondary Outcomes (7)

• Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A

  Baseline and Week 15

• Percentage of Participants Considered Responders at the End of Part A

  Week 15

• Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A

  Baseline and Week 15

• Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A

  Baseline and Week 15

• Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A

  Week 15

Study Arms (3)

Double-Blind Treatment Period - Part A: Placebo

PLACEBO COMPARATOR

Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.

Drug: Placebo

Double-Blind Treatment Period - Part A: Soticlestat

EXPERIMENTAL

Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.

Drug: Soticlestat

Open-Label Extension Period - Part B: Soticlestat

EXPERIMENTAL

Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.

Drug: Soticlestat

Interventions

Soticlestat DRUG

Soticlestat tablets

Also known as: TAK-935

Double-Blind Treatment Period - Part A: Soticlestat; Open-Label Extension Period - Part B: Soticlestat

Placebo DRUG

Soticlestat matching placebo tablets

Double-Blind Treatment Period - Part A: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant meets the Budapest clinical diagnosis of complex regional pain syndrome (CRPS) at the screening visit and is at least 6 months since onset of symptoms.
• Participant's pain medications and nondrug treatments must be stable (regimented per prescription) for 1 month prior to screening and remain stable throughout Part A.
• Participant agrees to use a single previously prescribed rescue medication within the prescribed dose during Part A of the study and to record the daily use of these medications.
• Participant must have an average 24-hour pain intensity score ≥4 and ≤9 on the 24-hour average pain intensity numeric pain scale (NPS) during screening/baseline. This score will be calculated by averaging the daily 24 hour pain intensity scores for the past seven days prior to randomization. The participant must have daily 24-hour pain intensity scores recorded for at least 6 of the past 7 days.

You may not qualify if:

• Currently receiving intravenous (IV) or oral ketamine, history of IV or oral ketamine use within the past 6 weeks prior to screening, or planned use of IV or oral ketamine during this study.
• Participant is receiving chronic opioid treatment at a dose that has not been stable 28 days prior to screening.
• Participant is receiving chronic opioid treatment \>160 mg of morphine equivalent per day.
• Participant has a positive drug screen for phencyclidine, amphetamine/ methamphetamine, or cocaine at screening. Cannabis is allowed..
• Participant is positive for hepatitis B or hepatitis C infection at screening. (Note that participants who have been vaccinated against hepatitis B \[hepatitis B surface antibody {Ab}-positive\] who are negative for other markers of prior hepatitis B infection \[eg, negative for hepatitis B core Ab\] are eligible. Also, note that participants who are positive for hepatitis C Ab are eligible if they have a negative hepatitis C viral load by quantitative polymerase chain reaction).

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (3)

St Pancras Clinical Research

London, England, WC1X 8QD, United Kingdom

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, England, PR2 9HT, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, England, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Ratcliffe S, Arkilo D, Asgharnejad M, Bhattacharya S, Harden RN. Randomized controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in adults with complex regional pain syndrome. Pain Med. 2023 Jul 5;24(7):872-880. doi: 10.1093/pm/pnac198.

  PMID: 36538782 DERIVED

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

soticlestat

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: July 23, 2019
• Primary Completion: June 29, 2020
• Study Completion: October 28, 2020
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

GB (3)