A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pai
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852
- Registration Number
- EUCTR2011-002901-31-GB
- Lead Sponsor
- Mundipharma Research GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 202
Screening/Double-Blind Phase Inclusion Criteria: 1. Males and females, age of 25 years or over 2. Able to provide written informed consent 3. Primary diagnosis of Parkinson's disease diagnosed by an expert as determined by the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (1992) 4. Parkinson's disease Stage II-IV (Hoehn & Yahr staging system) 5. Severe pain graded in at least 1 of the sub sections of the Chaudhuri and Schapira (2009) pain classification system 6. An average pain score of 6 or above on an 11 point NRS, over the previous 7 days determined using diary scores of averaged 24 hour pain in the 7 days leading up to Randomisation (assessed at Visit 2) 7. Female subjects less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use an adequate and highly effective method of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (hormonal), sexual abstinence or vasectomised partner. Subjects who have had a hysterectomy, sterilisation or who the Investigator is certain to be post-menopausal (e.g. are elderly) do not need to be tested. 8. Subjects who, based on the Investigators' judgement, are likely to benefit from WHO step III opioid therapy for the duration of the study 9. Subjects must not have received opioid containing medication in the last 6 months on a regular basis (i.e. prescribed medication or more than occasional self medication use for cough, cold etc.) 10. Receiving stable treatment for Parkinson's disease for at least 4 weeks prior to randomisation, the dose of which is expected to remain consistent throughout the Double-Blind Phase 11. In the Investigator's opinion, the subject does not have visual or auditory impairments that would reduce their ability to complete study questionnaires or be unable to receive instructions for these 12. Concomitant medication (including co-analgesic) use anticipated to remain stable throughout the Double-Blind Phase of the study 13. Subjects willing and able to participate in all aspects of the study and comply with the use of study medication. Open-Label Extension Inclusion Criteria: 1. Still meet general inclusion criteria for Double-Blind Phase; subjects do not have to meet inclusion 5, 6, 9 & 12 2. Have completed the Double-Blind Phase or discontinued early but have had at least 8 weeks treatment with study medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
Medical Conditions 1. Cognitive impairment as assessed with the Mini Mental State Examination (MMSE)scoring 24 or less 2. History of psychosis (hallucinations, delusions, etc.) 3. History of drug or alcohol abuse or current compulsive addictive use of drugs or alcohol 4. Parkinsonian-like disease secondary to drug therapy side-effects e.g. due to exposure to medications that deplete dopamine (reserpine, tetrabenazine) or block dopamine receptors (neuroleptics, antiemetics) 5. Parkinson-plus syndromes e.g. progressive supranuclear palsy (PSP) and the multiple system atrophies (MSA) 6. Females who are pregnant (positive ß-hCG test) or lactating 7. Any other contraindications to use of the opioid study medication(s) as per the SmPC/IB: - Hypersensitivity to the active substances or to any of the excipients - Any situation where opioids are contraindicated - Severe respiratory depression with hypoxia and/or hypercapnia - Severe chronic obstructive pulmonary disease - Cor pulmonale - Severe bronchial asthma - Non-opioid induced paralytic ileus - Moderate to severe hepatic impairment 8. Any other contraindications to use of the study Double-Blind Phase rescue medication as per the SmPC: - known hypersensitivity to levodopa or benserazide - contra-indicated in narrow-angle glaucoma (it may be used in wide-angle glaucoma provided that the intra-ocular pressure remains under control); severe psychoneuroses or psychoses; severe endocrine, renal, hepatic or cardiac disorders - should not be given in conjunction with, or within 2 weeks of withdrawal of, monoamine oxidase (MAO) inhibitors, except selective MAO-B inhibitors (e.g.selegiline) or selective MAO-A inhibitors (e.g. moclobemide) unless selective MAO inhibitors are given in combination in which case it is contraindicated - not be used in persons who have a history of, or who may be suffering from, a malignant melanoma 9. Subjects with any of the following as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication: - myxoedema - untreated hypothyroidism - Addison`s disease - increase of intracranial pressure - uncontrolled seizures or convulsive disorder - evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease (subjects with controlled co-morbidities may be included following agreement with the Medical Monitor) Contraindicated Treatments 10. Treatment with Deep Brain Stimulation 11. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigator's opinion, may pose a risk of additional CNS depression with opioids study medication 12. Subjects presently taking, or who have taken, naloxone or naltrexone = 30 days prior to the Screening Visit 13. Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Phase) 14. Any current use of an opioid other than the study medication provided 15. Subjects with a positive urine drug test at Screening Visit 1, which indicates unreported illicit drug use or unreported use of a concomitant medication not required to treat the Subjects' medical condition(s) 16. Abnormal parameters as defined: - aspartate aminotransferase (AST; SGOT) > 3 times the upper limit of normal - alanine aminotransferase (ALT; SGPT) > 3 times the upper limit of normal - alkaline ph
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method