Cognitive Changes With Gabapentin Treatment

NCT04106011 | Terminated FDA Drug

• 1 other identifier: 201908050
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-cohort, prospective, observational study evaluating the effects of gabapentin on cognition. The goal of the study is to determine whether there is a measurable change in cognitive function from baseline in patients who are prescribed gabapentin for the treatment of neuropathic pain.

Conditions

Neuralgia Peripheral; Pain

Outcome Measures

Primary Outcomes (1)

• Change in the Brief Test of Adult Cognition by Telephone (BTACT)

  Measure of cognitive functioning that assesses multiple dimensions central for effective functioning across adulthood: episodic memory, working memory, reasoning, verbal fluency, and executive functioning. Scoring: Word List Recall - Immediate \& Delayed Total number unique is total number of correct responses (range 0-15) Backward Digit Span Score is highest number of digits reached (range 0, 2-8) Category Fluency Total number unique is total number of correct responses Red/Green Accuracy Normal baseline score is total number correct in normal baseline condition (range 0-20) Number Series Total number of items correct (range 0-5) Backward Counting Last number reached Total number of errors Total number of digits produced is calculated as: 100 - (number reached + number errors)

  up to 6 weeks after treatment initiation

Secondary Outcomes (4)

• Change in pain severity - BPI

  up to 6 weeks after treatment initiation

• Change in Depression and Anxiety - HADS

  up to 6 weeks after treatment initiation

• Change in Sleep Problems - SLP9

  up to 6 weeks after treatment initiation

• Change in Neuropathic Pain - NPSI

  up to 6 weeks after treatment initiation

Study Arms (1)

Patients with Neuropathic Pain

Drug: Gabapentin; Diagnostic Test: BTACT; Diagnostic Test: BPI; Diagnostic Test: HADS; Diagnostic Test: SLP9; Diagnostic Test: NPSI

Interventions

Gabapentin DRUG

Titration of gabapentin will be standardized as 300mg QHS and increased by 300mg every 3 days until taking 1200mg TID or maximum tolerable dose. Subjects will undergo cognitive evaluation prior to initiation of the medication, at 1 week (when titrated to approximately 900mg/day), 3 weeks (when titrated to approximately 2100mg/day), and at 6 weeks (when titrated to 3600mg/day or maximum tolerable dose).

Patients with Neuropathic Pain

BTACT DIAGNOSTIC_TEST

Cognition measure: Brief Test of Adult Cognition by Telephone

Patients with Neuropathic Pain

BPI DIAGNOSTIC_TEST

Pain severity and interference at baseline using the Brief Pain Inventory

Patients with Neuropathic Pain

HADS DIAGNOSTIC_TEST

Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale

Patients with Neuropathic Pain

SLP9 DIAGNOSTIC_TEST

Assessment of Sleep

Patients with Neuropathic Pain

NPSI DIAGNOSTIC_TEST

Assessment of neuropathic components

Patients with Neuropathic Pain

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neuropathic pain, who are prescribed gabapentin per standard of care

You may qualify if:

• Age between 18 and 85
• Diagnosis of neuropathic pain
• Patient report of average daily pain intensity in the last week \>3 on 0-10 Numerical Rating Scale (NRS).
• Able and willing to sign an IRB-approved written informed consent

You may not qualify if:

• Current pregabalin treatment
• Patient has started taking a new pain medication, or has changed their pain medication dose, in the past 4 weeks.
• Treatment with opioids exceeding 60mg MME.
• Severe cognitive impairment that is documented in medical chart.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University Medical Center/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• Berger A, Sadosky A, Dukes E, Edelsberg J, Oster G. Clinical characteristics and patterns of healthcare utilization in patients with painful neuropathic disorders in UK general practice: a retrospective cohort study. BMC Neurol. 2012 Mar 6;12:8. doi: 10.1186/1471-2377-12-8.

  PMID: 22394606 BACKGROUND

• Finnerup NB, Attal N. Tapentadol prolonged release in the treatment of neuropathic pain related to diabetic polyneuropathy--authors' reply. Lancet Neurol. 2015 Jul;14(7):685-6. doi: 10.1016/S1474-4422(15)00060-5. No abstract available.

  PMID: 26067119 BACKGROUND

• Fleet JL, Dixon SN, Kuwornu PJ, Dev VK, Montero-Odasso M, Burneo J, Garg AX. Gabapentin dose and the 30-day risk of altered mental status in older adults: A retrospective population-based study. PLoS One. 2018 Mar 14;13(3):e0193134. doi: 10.1371/journal.pone.0193134. eCollection 2018.

  PMID: 29538407 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jessica Justmann, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: January 10, 2020
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

US (1)