Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)
Condition: Complex Regional Pain Syndrome
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Intervention: Soticlestat; Placebo
Intervention description: Soticlestat tablets; Soticlestat matching placebo tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug Therapy; Soticlestat; TAk-935

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).
    

Eligibility criteria:

        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).