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

Medtronic

Status and phase: Terminated; Phase 2

Conditions: Chronic Intractable Pain

Treatments: Drug: Intraspinal Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414466

1622

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

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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