Pregabalin in CIPN

NCT02394951 | Completed Results DMC

• 1 other identifier: 201501067
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators seek to investigate certain patient characteristics that would predict the response to a currently approved analgesic, pregabalin, in patients with chronic pain due to nerve damage caused by chemotherapy. Patients with this painful condition, called chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The investigators will recruit potential subjects from both the Siteman Cancer Center and the Washington University Pain Management Center. Those patients who meet the inclusion and satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and thermal sensitivity testing on their extremities, will provide quality of life information by completing questionnaires and will receive pregabalin followed by placebo, or placebo followed by pregabalin \[crossover design\] in order to assess how well the sensory tests predict the analgesic effect of pregabalin (compared to placebo).

Conditions

Neuropathy; Pain

Keywords

chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in Spontaneous Pain Intensity as a Function of Baseline MPT

  Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.

  Baseline to week 4

Secondary Outcomes (6)

• Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)

  Baseline to week 4

• Change in NPSI Outcomes

  Baseline to week 4

• Change in BPI Outcomes (SEVERITY)

  Baseline to week 4

• Change in Sleep Problem Index (SPI) Outcomes

  Baseline to week 4

• Change in BPI Outcomes (INTERFERENCE)

  baseline to week 4

Study Arms (2)

Pregabalin

EXPERIMENTAL

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Drug: Pregabalin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Drug: Pregabalin; Drug: Placebo

Interventions

Pregabalin DRUG

Anticonvulsant

Also known as: Lyrica

Placebo; Pregabalin

Placebo DRUG

Identical, matching inactive substance

Placebo; Pregabalin

Eligibility Criteria

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

You may qualify if:

• Age \>18
• Distal symmetric pain distribution (both feet, with or without pain in hands).
• The pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these.
• Score of 4 or more on DN4 (Douleur Neuropathique 4) neuropathic pain questionnaire
• Pain duration \> 2 months.
• Patient report of average daily pain intensity in the last week \>3 on 0-10 Numerical Rating Scale (NRS).
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation.
• Able and willing to sign an IRB-approved written informed consent.

You may not qualify if:

• Hypersensitivity to pregabalin.
• Current treatment with pregabalin.
• Current treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or CIPN that may be associated with previous treatment with a vinca alkaloid.
• History of diabetes mellitus or a neurological disorder with any previous signs of distal symmetric polyneuropathy.
• Moderate to severe renal failure (Creatinine clearance \< 30mL/min, by Cockcroft-Gault formula).
• ALT (alanine aminotransferase) or AST (aspartate aminotransferase ) \> 3 times the upper limit of normal.
• Inability to complete pain self-report.
• Pregnancy or lactation
• Patients with seizure disorders treated with anticonvulsants
• Current participation in a trial with another investigational agent.
• Concomitant medication as follows:
• Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation.
• Patients on antidepressant treatment for pain or depression (TCAs, SSRI, SNRIs etc. will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation. No dose regimen changes of antidepressants will be allowed during the study period.
• Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation. The maximum allowed dose of opioid will be equivalent to 60mg oral morphine sulphate. Patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study. Short-acting opioids for painful CIPN treatment will not be allowed.
• Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) will be discontinued at least 2 weeks before study initiation. However, low-dose aspirin (≤325mg/day) will be allowed.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Early termination due to slow recruitment

Results Point of Contact

• Title: Dr. Simon Haroutounian
• Organization: Washington University in Saint Louis

sharout@wustl.edu

3143622628

Study Officials

• Simon Haroutounian, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 20, 2015
• Study Start: April 1, 2015
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: May 14, 2019
• Results First Posted: May 14, 2019

Record last verified: 2019-04

Locations

US (1)