The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain

NCT02969629 | Completed Phase 4

• 1 other identifier: 0234-11-RMB
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized double-blinded manner.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Experimental and clinical cold pain tolerance measured in seconds

  Up to 120 minutes after drug administration

Secondary Outcomes (2)

• Experimental and clinical cold pain threshold measured in seconds

  Up to 120 minutes after drug administration

• Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)

  Up to 120 minutes after drug administration

Study Arms (2)

apomorphine

EXPERIMENTAL

1.5 mg apomorphine, administered subcutaneously

Drug: Apomorphine

Normal saline

PLACEBO COMPARATOR

saline, administered subcutaneously

Drug: Normal Saline

Interventions

Apomorphine DRUG

apomorphine

Normal Saline DRUG

Normal saline

Eligibility Criteria

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

You may qualify if:

• Presence of radicular pain for at least 3 months;
• Average pain level during the last week prior to enrollment \> 40 (0-100);
• No use of a new analgesic drug within 30 days prior to entry to the study and
• Adults who were capable of understanding the purpose and instructions of the study and signing an informed consent.

You may not qualify if:

• Pregnancy or breastfeeding;
• Presence of Parkinson's disease or any other extra-pyramidal diseases;
• History of allergy to the investigational drugs: Apomorphine or Domperidone;
• History of polyneuropathy and
• Respiratory depression, dementia, psychotic diseases or hepatic insufficiency

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Interventions

Apomorphine; Saline Solution

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Elon Eisenberg, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pain research unit, Institute of pain

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: November 21, 2016
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)