Study of TAK-935 as an Adjunctive Therapy in Adult Subjects With Complex Regional Pain Syndrome
- Conditions
- Complex Regional Pain Syndrome (CRPS)MedDRA version: 21.1Level: LLTClassification code 10064334Term: Complex regional pain syndrome Type ISystem Organ Class: 100000004852MedDRA version: 21.1Level: LLTClassification code 10064335Term: Complex regional pain syndrome Type IISystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-004750-21-GB
- Lead Sponsor
- Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
2. The subject signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures, including requesting that a subject fast for any clinical laboratory evaluations.
3. The subject is a male or female aged =18 to 75 years inclusive at the time of informed consent.
4. The subject meets the Budapest clinical diagnosis of CRPS at the screening visit, and is at least 6 months since onset of symptoms.
The Budapest/International Association for the Study of Pain clinical criteria:
a. Continuing pain, which is disproportionate to any inciting event.
b. Must report at least 1 symptom in 3 of the following symptom categories:
i. Sensory: Reports of hyperalgesia and/or allodynia.
ii. Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetries.
iii. Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry.
iv. Motor/trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
c. Must display at least 1 sign (observed at evaluation) in 2 or more sign categories:
i. Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic pressure and/or joint movement).
ii. Vasomotor: Evidence of temperature asymmetry (>1.0°C) and/or skin color changes and/or sweating asymmetry.
iii. Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry.
iv. Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
d. No other diagnosis that better explains the signs and symptoms.
5. The subject has a history of failure of one or more standard of care therapies for the treatment of CRPS as judged by the investigator.
6. The subject’s pain medications and nondrug treatments must be stable (regimented per prescription) for 1 month prior to screening and remain stable throughout Part A.
7. The subject 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.
8. The subject must have an average 24-hour pain intensity score =4 and =9 on the 24-hour average pain intensity 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 subject must have daily 24-hour pain intensity scores recorded for at least 6 of the past 7 days.
9. The subject is not involved in active litigation related to CRPS.
10. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose.
11. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose.
12. The subject must agree to never post any personal medical data related to the study or information related to the study
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. The subject has received any excluded medications, procedures, or treatments during the time periods listed in the protocol.
3. The subject has any unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance.
4. The subject has any history of convulsions (excluding febrile seizures in childhood) or is at an increased risk for convulsions.
5. The subject has any history of alcohol, opioid, or moderate to severe substance use disorder (except nicotine and cannabis), as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within the 2 years immediately prior to the screening visit (Visit 1).
6. Subject is receiving chronic opioid treatment at a dose that has not been stable 28 days prior to screening.
7. Subjects is receiving chronic opioid treatment >160 mg of morphine equivalent per day.
8. The subject has a positive drug screen for phencyclidine, amphetamine/ methamphetamine, or cocaine at screening. Cannabis is allowed.
9. The subject is considered by the investigator to be at imminent risk of suicide or injury to self,
others, or property, or the subject has attempted suicide within the past year prior to screening. Subjects who have positive answers on item number 4 or 5 on the C-SSRS (based on the past year) prior to randomization are excluded.
10. The subject has or any first-degree family members have a history of psychosis, bipolar disorder, or schizophrenia.
11. The subject has cataracts based on investigator opinion.
12. The subject is positive for hepatitis B or hepatitis C infection at screening. (Note that subjects 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 subjects who are positive for hepatitis C Ab are eligible if they have a negative hepatitis C viral load by quantitative polymerase chain reaction).
13. The subject has abnormal and clinically significant ECG abnormality at screening as determined by the investigator. Subject has a QT interval with Fridericia’s correction method(QTcF) >450 ms (males) or >470 ms (females), confirmed with 1 repeat testing, at screening.
14. The subject has abnormal clinical laboratory test results at screening that suggest a clinically significant underlying disease that would compromise the well-being of the subject (if the subject has alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >2.5 × the upper limit of normal [ULN], the medical monitor should be consulted).
15. The subject has a known hypersensitivity to any component of the formulation of TAK-935.
16. The subject has been part of a clinical study involving another investigational product in the previous 3 months prior to screening or subject is currently receiving an investigational product.
17. The subject h
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of TAK-935 on calculated 24-hour average pain intensity by the Numeric Pain Scale (NPS);Secondary Objective: To investigate the effect of TAK-935 on overall function using the Patient Global Impression of Change (PGIC) and the Patient-Reported Outcomes Measurement Information System (PROMIS-29) scale.<br><br> To investigate the effect of TAK-935 on the CRPS Severity Score (CSS).<br><br> To investigate the effect of TAK-935 on responder rate (responder is defined as =30% improvement in the 24-hour pain intensity).;Primary end point(s): Change in mean 24-hour pain intensity NPS from baseline to the end of Part A (Week 15);Timepoint(s) of evaluation of this end point: End of Part A (week 15)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Percent change in mean 24-hour pain intensity NPS score from baseline to the end of Part A (Week 15).<br><br>- Percent of responders (defined as =30% improvement on the 24-hour pain intensity NPS) by the end of Part A (Week 15).<br><br>- Change and percent change from baseline of mean total score of the PROMIS 29 version 2 to the end of Part A (Week 15).<br><br>- Change and percent change from baseline of mean PGIC to the end of Part A (Week 15).<br><br>- Change and percent change from baseline of mean CSS in subjects to the end of Part A (Week 15).;Timepoint(s) of evaluation of this end point: End of Part A (week 15)