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Trial record 6 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Reflex Sympathetic Dystrophy"

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

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ClinicalTrials.gov Identifier: NCT03990649
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to investigate the effect of TAK-935 on calculated 24-hour average pain intensity by the numeric pain scale (NPS).

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Drug: TAK-935 Drug: TAK-935 Placebo Phase 2

Detailed Description:

The drug being tested in this study is called TAK-935. TAK-935 is being tested to treat people with chronic complex regional pain syndrome (CRPS). This study will look at the efficacy, safety, and tolerability of TAK-935 as an adjunctive therapy in participants with CRPS.

The study will enroll approximately 24 patients. Participants will be randomly assigned (by chance, like flipping a coin) in 2:1 ratio to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

TAK-935 100 mg tablets, 100, 200 or 300 mg BID Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

Participants will receive 100 mg TAK-935 tablets or placebo-matching TAK-935 tablets, BID for Week 1, 2x100 mg TAK-935 tablets or placebo-matching TAK-935 tablets, BID for Week 2 and followed by 3x100 mg TAK-935 tablets or placebo-matching TAK-935 tablets, BID for Week 3. Dose will be uptitrated based on safety and tolerability in titration period. Participants will continue to receive the same dose in maintenance period. Dose adjustments during maintenance period may take place due to safety and tolerability.

Participants will then enter Part B (optional) or taper period. In Part B all participants will receive TAK-935 2x100 mg tablets, BID for 1 Week, followed by TAK-935 3x100 mg tablets, BID for 1 Week. Dose will be uptitrated/downtitrated based on safety and tolerability in titration period (Part B), participants will continue to receive the same dose in maintenance period (Part B) and followed by a taper period.

This multi-center trial will be conducted in United Kingdom. The overall time to participate in this study is approximately 36 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone 15 days after last dose of study drug for a follow-up assessment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Adult Subjects With Chronic Complex Regional Pain Syndrome
Estimated Study Start Date : July 26, 2019
Estimated Primary Completion Date : May 17, 2020
Estimated Study Completion Date : August 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A: TAK-935
Part A (Double blind titration period): Tablets, TAK-935, 100 mg, orally, twice daily (BID) for Week 1, followed by tablets, TAK-935, 200 mg, orally, BID for Week 2, further followed by tablets, TAK-935, 300 mg, orally, BID for Week 3. Dose will be uptitrated every week based on safety and tolerability. Part A (Double blind maintenance period): Tablets, TAK-935 300 mg, orally BID for 12 weeks. Dose adjustments during maintenance period may take place due to safety and tolerability. Taper period (if participant does not continue to Part B): Dose of TAK-935 to be reduced to next lower dose every 3 days (maximum 6 days) till TAK-935 is discontinued.
Drug: TAK-935
TAK-935 Tablets

Placebo Comparator: Part A: Placebo
TAK-935 placebo-matching tablets, orally, BID for Weeks 1, 2 and 3 in Double blind titration period. TAK-935 placebo-matching tablets, orally BID for 12 weeks in Double blind maintenance period. Taper period (if participant does not continue to Part B): Dose of TAK-935 placebo-matching tablets to be reduced to next lower dose every 3 days (maximum 6 days) till TAK-935 is discontinued.
Drug: TAK-935 Placebo
TAK-935 placebo-matching tablets

Experimental: Part B: TAK-935
Part B (Optional, Open label extension: titration period all participants to receive TAK-935): Tablets, TAK-935, 200 mg, orally, BID up to 1 week followed by tablets, TAK-935, 300 mg, orally, BID for up to 1 week. Dose will be uptitrated every week based on safety and tolerability. Part B (Open label extension: maintenance period): Tablets, TAK-935 300 mg, orally BID for 12 weeks. Dose adjustments during maintenance period may take place due to safety and tolerability. Taper period: Dose of TAK-935 to be reduced to next lower dose every 3 days (maximum 6 days) till TAK-935 is discontinued.
Drug: TAK-935
TAK-935 Tablets




Primary Outcome Measures :
  1. Change from Baseline in Mean 24-Hour Pain Intensity as Assessed by Numeric Pain Scale (NPS) Score to the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    The 24-hour average pain intensity (NPS, an 11 point scale, 0-10, 0= no pain to 10 = most pain imaginable) will be calculated from current pain intensity scores collected 3 times a day as measured by the electronic pain diary daily during Parts A and B. Pain intensity will be evaluated on the affected limb. If more than 1 limb is involved, the participant and the investigator will determine which limb is the most problematic and the pain will be evaluated for that limb throughout the study.


Secondary Outcome Measures :
  1. Percent Change from Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    The 24-hour average pain intensity (NPS, an 11-point scale, 0-10, 0= no pain to 10 = most pain imaginable) will be calculated from current pain intensity scores collected 3 times a day as measured by the electronic pain diary daily during Parts A and B. Pain intensity will be evaluated on the affected limb. If more than 1 limb is involved, the participant and the investigator will determine which limb is the most problematic and the pain will be evaluated for that limb throughout the study.

  2. Percentage of Participants with Response at the End of Part A (Week 15) [ Time Frame: Week 15 ]
    Response is defined as ≥ 30% improvement on the 24-hour pain intensity assessed by NPS score. The 24-hour average pain intensity (NPS, an 11-point scale, 0-10, 0= no pain to 10 = most pain imaginable) will be calculated from current pain intensity scores collected 3 times a day as measured by the electronic pain diary daily during Parts A and B. Pain intensity will be evaluated on the affected limb. If more than 1 limb is involved, the participant and the investigator will determine which limb is the most problematic and the pain will be evaluated for that limb throughout the study.

  3. Change from Baseline of Mean Total Score of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2 at the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    The PROMIS-29 (version 2), a generic health-related quality of life survey, assesses each of the 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions per domain. The questions are ranked on a 5-point Likert scale. The scale ranges from 1-5 in each domain: depression (1=never and 5=always); anxiety (1=never and 5=always); physical function (1=unable to do and 5 =without any difficulty); pain interference (1=not at all and 5=very much); fatigue (1=not at all and 5=very much); sleep disturbance (1=very much and 5=not at all); ability to participate in social roles and activities (1=always and 5=never).

  4. Percent Change from Baseline of Mean Total Score of PROMIS-29) Version 2 at the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    The PROMIS-29 (version 2), a generic health-related quality of life survey, assesses each of the 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions per domain. The questions are ranked on a 5-point Likert scale. The scale ranges from 1-5 in each domain: depression (1=never and 5=always); anxiety (1=never and 5=always); physical function (1=unable to do and 5 =without any difficulty); pain interference (1=not at all and 5=very much); fatigue (1=not at all and 5=very much); sleep disturbance (1=very much and 5=not at all); ability to participate in social roles and activities (1=always and 5=never).

  5. Change From Baseline of Mean Patient Global Impression of Change (PGIC) Scale at the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    The PGIC is a 7-point Likert scale to address the following question: Since beginning treatment at this clinic would you describe any changes (if any) in activity, limitations, symptoms, emotions and overall quality of life related to your painful condition compared to before treatment? Very much improved; moderately improved; slightly improved; no change; slightly worse; moderately worse; very much worse.

  6. Percent Change From Baseline of Mean PGIC Scale at the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    The PGIC is a 7-point Likert scale to address the following question: Since beginning treatment at this clinic would you describe any changes (if any) in activity, limitations, symptoms, emotions and overall quality of life related to your painful condition compared to before treatment? Very much improved; moderately improved; slightly improved; no change; slightly worse; moderately worse; very much worse.

  7. Change From Baseline of Mean CRPS Severity Score (CSS) at the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS have been incorporated into a clinically feasible CSS. Signs and symptoms include relevant features of CRPS that are scored for their presence (1) or absence (0), eg, dystrophic changes to hair and nails, decreased range of motion, and motor weakness comprise the motor/trophic features of CRPS. Total CSS is a 16-point score with 8 signs and 8 symptoms.

  8. Percent Change From Baseline of Mean CSS at the End of Part A (Week 15) [ Time Frame: Baseline to Week 15 ]
    Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS have been incorporated into a clinically feasible CSS. Signs and symptoms include relevant features of CRPS that are scored for their presence (1) or absence (0), eg, dystrophic changes to hair and nails, decreased range of motion, and motor weakness comprise the motor/trophic features of CRPS. Total CSS is a 16-point score with 8 signs and 8 symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Has cataracts based on investigator opinion.
  6. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990649


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03990649     History of Changes
Other Study ID Numbers: TAK-935-2008
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug Therapy

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases