A study of EMA401 in the treatment of pain due to nerve injury.
- Conditions
- Peripheral neuropathy due to nerve injuryNeurological - Other neurological disorders
- Registration Number
- ACTRN12611001185954
- Lead Sponsor
- Spinifex Pharmaceuticals Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 40
Patients who:
1. Are able to give voluntary written informed consent to participate in the study.
2. Are 18 to 80 years old inclusive.
3. Have had focal peripheral neuropathic pain for least 3 months prior to Screening that is related to nerve injury caused by trauma or surgery not associated with ongoing infection (examples include post-thoractomy syndrome, post-mastectomy syndrome, post-inguinal herniorrhaphy syndrome, post-radical neck dissection syndrome, traumatic neuropathies (bullet wounds, lacerations, road traffic accidents)).
4. Have a location of pain consistent with the area innervated by the affected nerve(s), with or without other sensory symptoms in the affected area.
5. Be diagnosed as suffering from moderate to severe pain across the Screening period. The assessment of moderate and severe pain will be made using an algorithm proprietary to Spinifex Pharmaceuticals. The investigator will be informed immediately as to whether the patient is eligible or ineligible on entering all the relevant pain scores in the electronic data capture portal.
6. Are female of non-child-bearing potential (i.e. either surgically sterilised or one year post-menopausal), or if of child-bearing potential, must have used adequate contraceptive precautions for 30 days prior to Screening, and must agree to use two approved methods of contraception for the duration of the study and for one month after administration of the last dose of study medication
OR
Are male and agree to use two approved methods of contraception for the duration of the study and until one month after administration of the last dose of the study medication.
7. Are able to read and understand the language of the scales and questionnaires used during the study.
8. Are contactable via telephone.
Patients who:
1. Are pregnant or breast-feeding.
2. Do not and cannot comply with the protocol concomitant medication restrictions.
3. Have received an investigational drug within 30 days or 10 half-lives of the drug, whichever is longer, prior to the Screening visit.
4. Have previously received EMA401.
5. Are known to be allergic to EMA401 or any of the excipients.
6. Have a clinically significant history of systemic allergic disease (e.g., urticaria, atopic dermatitis).
7. Have a history of an allergic reaction to previous medication that required management by a health care professional.
8. Have non-peripheral nerve injury neuropathic pain component, or more than one cause or potential cause of pain symptoms.
9. Have deafferentation pain (spinal root avulsion injury, lumbo-sacral root pain).
10. Have intractable pain of unknown origin or active infection in the area of nerve injury.
11. Have had extensive surgery for the treatment of their nerve injury.
12. Have skin conditions in the affected area that in the investigator’s opinion could alter sensation.
13. Have any history of clinically significant cardiac arrhythmias or the presence of clinically significant abnormalities on electrocardiogram (ECG) at screening.
14. Have systolic blood pressure <100 or >150 mmHg, or a diastolic blood pressure < 50 or >90 mmHg on two consecutive measurements at least 10 minutes apart.
15. Have a resting pulse rate >100 or <50 beats per minute on two consecutive measurements at least 10 minutes apart.
16. Have a calculated creatinine clearance (using Cockroft and Gault formula) of less than 50 mL/min at Screening.
17. Have serum aspartate transaminase (AST), gamma glutamyl transaminase (GGT) or alanine transaminase (ALT) levels greater than 3.0 x the upper limit of normal or have total bilirubin concentrations greater than 2.0 x the upper limit of normal at Screening.
18. Have current hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infection.
19. Consume more than four units of alcohol daily for a man or three units of alcohol for a woman (one unit = 300 mL beer, one glass of wine, one measure of spirits) or have a history of alcohol abuse/dependence.
20. Other than the condition under study, have an active, uncontrolled medical condition, or psychiatric illness, or any other significant clinical disorder or laboratory finding that in the opinion of the investigator, precludes participation in the study or may interfere with the study objectives.
21. Other than the condition under study, have had a clinically significant illness or operative procedure within 4 weeks of the Screening visit.
22. Are known to be poor compliers or those unlikely to attend study visits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method