CRPS-RISE Clinical Trial

Now Enrolling Participants

Do you or someone you know have ongoing pain, swelling, or changes in skin color or temperature after an injury or surgery?

Doctors and researchers are studying a possible new treatment for Complex Regional Pain Syndrome Type 1 (CRPS-1).

Complex Regional Pain Syndrome (CRPS) is a painful condition that can happen after an injury, surgery, fracture, sprain, or other trauma

Symptoms may include:

• Burning sensation or disproportionate pain in the arm, leg, foot, or hand
• Swelling 
• Changes in skin color or temperature
• Sensitivity to touch
• Trouble moving the affected limb

This study is testing an investigational medication called AMBTX-01 to see if it may:

• Reduce CRPS pain
• Improve movement and daily functioning
• How safe the treatment is

Participants will receive either:

• AMBTX-0, or 
• Placebo (a treatment with no active medication

The assignment is random, like flipping a coin. Neither you or the study team will know which treatment you receive during the study.

You may qualify if you:

• Are 18 years or older
• Have been diagnosed with CRPS-1
• Developed CRPS symptoms within the last 6 months
• Have moderate to severe pain
• Have swelling, warmth, or redness in the affected area

The study team will review additional requirements with you.

The full study lasts about 18 weeks.

Screening Period (2 to 6 weeks)

Before joining, you will complete tests to see if the study is a good fit for you. These may include:

• Physical exam
• Blood and urine tests
• Heart tests (ECGs)
• Pain questionaires
• Bone scan
• Daily pain diary training

Treatment Visits

Participants will receive 4 IV infusions (Days 1, 4, 7, 10). Each infusion will last at least 2 hours.

Follow-up Visits

After treatment, you will return for follow-up visits over the next several weeks so the study team can check your:

• Pain levels
• Movement and function
• Overall health and safety

Like all medications, AMBTX-01 may cause side effects.

Possible side effects may include:

• Flu-like symptoms
• Fever
• Muscle aches
• Fatigue
• Low calcium levels
• Pain or discomfort at the IV site

The study team will monitor your health closely throughout the study.

Study-related treatment and procedures will be provided at no cost to participants.

You may be compensated for the visits and completion of a daily electronic diary. Please ask the study team for details.

If you would like to learn whether you may qualify for the CRPS-RISE study, please complete the contact form here and a study coordinator will reach out to you.

Read More: https://crps-rise.com/