Can a Brain-Targeting drug quiet the pain of CRPS?
NCT ID NCT03990649
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.
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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 Hide 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Spinal cord stimulator may calm the 'fight or flight' system in chronic pain
- Rewiring the brain to silence chronic pain — a bold psychological therapy is put to the test
- Oxygen therapy could be new weapon against chronic pain
- Could gabapentin or oxcarbazepine ease chronic nerve pain in kids?
- Could a simple questionnaire replace In-Person exams for CRPS?