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Can a Brain-Targeting drug quiet the pain of CRPS?

NCT ID NCT03990649

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether soticlestat, an experimental tablet, can reduce pain in adults with chronic complex regional pain syndrome (CRPS) that has lasted at least six months. About 24 participants will take either soticlestat or a placebo alongside their usual pain treatments for the first part of the study. They will record their pain three times a day using a 0-to-10 scale, and the study will compare average daily pain scores between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
soticlestat, an experimental tablet also known as TAK-935
What this could lead to
If it works, soticlestat could become a new add-on option for people whose complex regional pain syndrome has not responded to standard treatments.
What could go wrong
This is a small, early-stage trial of 24 people, so any pain relief seen may not hold up in larger studies. Soticlestat can cause side effects, and participants must keep their other pain treatments stable during the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Jul 2019

Finished

Oct 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. Exclusion Criteria: 1. 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. 2. Participant is receiving chronic opioid treatment at a dose that has not been stable 28 days prior to screening. 3. Participant is receiving chronic opioid treatment \>160 mg of morphine equivalent per day. 4. Participant has a positive drug screen for phencyclidine, amphetamine/ methamphetamine, or cocaine at screening. Cannabis is allowed.. 5. 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, England, PR2 9HT, United Kingdom

  • St Pancras Clinical Research

    London, England, WC1X 8QD, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, England, SO16 6YD, United Kingdom

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