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A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain

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Medtronic

Status and phase

Terminated
Phase 2

Conditions

Chronic Intractable Pain

Treatments

Drug: Intraspinal Gabapentin

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.

Enrollment

254 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Chronic pain below the neck present for a minimum of one year.

  • Diagnosis of at least one of the following:

    • back pain with or without leg pain,
    • post-herpetic neuralgia,
    • complex regional pain syndrome (CRPS) 1 or 2,
    • diabetic neuropathy,
    • or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

254 participants in 4 patient groups, including a placebo group

Placebo (0mg/day)
Placebo Comparator group
Description:
Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
Treatment:
Drug: Intraspinal Gabapentin
Gabapentin Low (1mg/day)
Active Comparator group
Description:
Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Treatment:
Drug: Intraspinal Gabapentin
Gabapentin Medium (6mg/day)
Active Comparator group
Description:
Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Treatment:
Drug: Intraspinal Gabapentin
Gabapentin High (30mg/day)
Active Comparator group
Description:
Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Treatment:
Drug: Intraspinal Gabapentin

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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