Study Assessing Pain Relief After Replacement of the Knee

NCT05260008 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ATX-101-TKA-003
• Study Type: interventional
• Target: 112
• Locations: 3 countries
• Sites: 13

Brief Summary

This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)

Conditions

Acute Postoperative Pain

Keywords

postoperative pain; post-surgical pain total knee arthroplasty; total knee replacement ATX-101; bupivacaine; bupivacaine implant

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity.

  NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).

  from 30 minutes post-surgery through hour 168 (Day 8)

Secondary Outcomes (3)

• Percentage of Subject Who Remain Opioid Free.

  Surgical Closure to Day 30

• Total Post-surgical Use of Rescue Opioid Medications.

  Surgical Closure to Day 30, Opioid consumption is summarized descriptively every 24-hour period through Day 30

• Time to First Rescue Opioid Medication.

  Surgical Closure to Day 30

Study Arms (3)

ATX-101 Dose A

EXPERIMENTAL

ATX-101 Dose A

Drug: ATX-101

ATX-101 Dose B

EXPERIMENTAL

ATX-101 Dose B

Drug: ATX-101

bupivacaine hydrochloride

ACTIVE COMPARATOR

bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block

Drug: bupivacaine hydrochloride without epinephrine

Interventions

ATX-101 DRUG

ATX-101 (bupivacaine) implant, one-time administration into the surgical site

ATX-101 Dose A

bupivacaine hydrochloride without epinephrine DRUG

bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration and/or nerve block

bupivacaine hydrochloride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis.
• Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted).
• American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2 or 3.

You may not qualify if:

• Has a planned concurrent surgical procedure.
• Has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening.
• Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee.
• Immunocompromised or has a known history of Hepatitis B, human immunodeficiency virus (HIV), or Hepatitis C.
• Routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial.
• Unable to abstain from opioid use for knee pain within 14 days of surgery.
• Has been administered systemic steroids within 14 days prior to surgery.
• Has been administered any local anesthetic within 5 days prior to the scheduled surgery.
• Screening electrocardiogram (ECG) with significant abnormalities associated with significant heart disease.
• Has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications.
• Has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments.
• Has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome.
• Has a known or suspected history of drug or alcohol abuse. A subject with a history of alcohol use disorder that has ≥10 years sobriety will be permitted.
• Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine.
• Has a Body Mass Index (BMI) ≥45 kg/m2

Sponsors & Collaborators

• Allay Therapeutics, Inc.: lead

Study Sites (13)

Prince of Wales Private Hospital

Sydney, New South Wales, 2031, Australia

Location

John Flynn Private Hospital

Tugun, Queensland, 4224, Australia

Location

Royal Adelaide Hospital / PARC Clinical Research

Adelaide, South Australia, 5000, Australia

Location

St Andrew's Private Hospital

Adelaide, South Australia, 5000, Australia

Location

The Avenue Private Hospital

Windsor, Victoria, 3181, Australia

Location

Durham Bone and Joint Specialists

Ajax, Ontario, L1S 7K7, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, C9 124, Canada

Location

Department of Trauma and Orthopaedic Surgery, Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Royal National Orthopaedic Hospital

Stanmore, Middlesex, HA7 4LP, United Kingdom

Location

Nottingham Elective Orthopaedic Service, Nottingham University Hospitals

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Robert Jones & Agnes Hunt Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Chapel Allerton Hospital C/O The Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Study Director
• Organization: Allay Therapeutics, Inc

clinicaltrialsinfo@allaytx.com

669-679-5081

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 2B, randomized, double blind, active comparator multicenter trial in participants undergoing total knee arthroplasty.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: June 7, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); CA (2); GB (6)