Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Central Neuropathic Pain; Allodynia; Spinal Cord Injury

Treatments: Drug: Placebo (Dextromethorphan); Drug: Dextromethorphan; Drug: Placebo (Lidocaine); Drug: Lidocaine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02218203

2000p001387

R01NS041503

Details and patient eligibility

About

This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.

Full description

This trial has several objectives:

Primary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.

Secondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and lidocaine in attenuating pain related to central nervous system sensitization, specifically spontaneous pain, mechanical allodynia, and hyperalgesia.

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
3. Serum laboratory examination obtained at study entry:
4. Normal cognitive function.
5. Signed informed consent.

Exclusion criteria

1. Pregnancy or breast-feeding.
2. Renal or hepatic dysfunction.
3. Significant cardiac disease (e.g. MI within 1 year).
4. Signs or symptoms of central neurological disorder, excluding SCI.
5. Severe psychological disorder requiring treatment.
6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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26 participants in 16 patient groups, including a placebo group

Placebo- 0mg/kg Lido

Placebo Comparator group

Description:

Placebo in combination with 0mg/kg LBM lidocaine

Treatment:

Drug: Placebo (Lidocaine)

Drug: Placebo (Dextromethorphan)

Placebo - 1mg/kg Lido

Experimental group

Description:

Placebo in combination with 1mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Placebo (Dextromethorphan)

Placebo - 2mg/kg Lido

Experimental group

Description:

Placebo in combination with 2mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Placebo (Dextromethorphan)

Placebo - 4mg/kg Lido

Experimental group

Description:

Placebo in combination with 4mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Placebo (Dextromethorphan)

Low Dose Dex - 0mg/kg Lido

Experimental group

Description:

Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Treatment:

Drug: Placebo (Lidocaine)

Drug: Dextromethorphan

Low Dose Dex - 1mg/kg Lido

Experimental group

Description:

Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

Low Dose Dex - 2mg/kg Lido

Experimental group

Description:

Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

Low Dose Dex - 4mg/kg Lido

Experimental group

Description:

Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

Medium Dose Dex - 0mg/kg Lido

Experimental group

Description:

Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Treatment:

Drug: Placebo (Lidocaine)

Drug: Dextromethorphan

Medium Dose Dex - 1mg/kg Lido

Experimental group

Description:

Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

Medium Dose Dex - 2mg/kg Lido

Experimental group

Description:

Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

Medium Dose Dex - 4mg/kg Lido

Experimental group

Description:

Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

High Dose Dex - 0mg/kg Lido

Experimental group

Description:

High dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Treatment:

Drug: Placebo (Lidocaine)

Drug: Dextromethorphan

High Dose Dex - 1mg/kg Lido

Experimental group

Description:

High dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

High Dose Dex - 2mg/kg Lido

Experimental group

Description:

High dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan

High Dose Dex - 4mg/kg Lido

Experimental group

Description:

High dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Treatment:

Drug: Lidocaine

Drug: Dextromethorphan