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| An open-label, escalating dose, proof of concept study to determine the effects of single oral doses of PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12 |
| ISRCTN | ISRCTN81647490 |
| ClinicalTrials.gov identifier | |
| Public title | An open-label, escalating dose, proof of concept study to determine the effects of single oral doses of PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | PSD506-OAB-002 |
| Study hypothesis | PSD506 is a novel selective muscarinic receptor antagonist that is being developed for the treatment of neurogenic detrusor overactivity in patients with spinal cord injury. Volume provocation tests in patients with spinal cord injury have previously been reported to be useful in assessing new putative treatments for neurogenic detrusor overactivity in spinal cord injury. This study aims to establish the volume provocation test as a surrogate endpoint for demonstrating the efficacy of PSD506 on urinary bladder contractions. This study will also assess the safety of PSD506 in subjects with neurogenic detrusor overactivity due to a spinal cord injury, and will investigate the effect on detrusor instability and function in this patient group. |
| Lay summary | |
| Ethics approval | Wandsworth Research Ethics Committee on 17/10/06 (ref: 06/Q0803/161) |
| Study design | This is an open-label, single-centre, escalating dose, proof of concept study of the effects of single doses of PSD506 on volume provocation tests in subjects with stable spinal injuries above T12. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Subjects with a diagnosis of detrusor hyper-reflexia secondary to spinal injury (mid-thoracic or cervical level) |
| Participants - inclusion criteria |
1. Male or female subjects, aged 18 years or over
2. Spinal lesion above T12, which has been stable for at least 6 months prior to screening. 3. Detrusor hyper- reflexia secondary to spinal injury (mid-thoracic or cervical level) present for at least 12 months 4. If female, must either be surgically sterile or post-menopausal for the past year confirmed by a negative hormone panel (luteinizing hormone [LH], follicle stimulating hormone [FSH], 17β estradiol), or if of child-bearing potential be on adequate non-hormonal contraception (not oral or injectable) i.e. double barrier method or intrauterine contraceptive device [IUCD]. If male must also use adequate contraception (hormonal methods permitted) 5. Anti-muscarinic-naïve or treated subjects completing the 5 day wash-out period. 6. Written informed consent |
| Participants - exclusion criteria |
1. If female, has a positive urine pregnancy test
2. History of drug or alcohol abuse 3. Use of anti-muscarinic agents with a long-half life e.g. solifenacin. 4. Body Mass Index (BMI) greater than 28 or less than 16 5. Mean sitting BP greater than 150/85 or less than 100/60 mmHg 6. Mean HR greater than 90 bpm or less than 50 bpm 7. Clinically significant orthostatic hypotension present at screening 8. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness 9. History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure 10. History of significant central nervous system disease, including: transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances 11. History of peripheral vascular or cerebrovascular disease 12. History of narrow angle glaucoma or increased ocular pressure 13. Clinically significant bladder pathology, including urinary tract infection within 6 weeks of Day 0 14. History of diabetes 15. Clinically significant GI disorder which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study 16. History of clinically significant liver disease, e.g., hepatitis B 17. Prohibited medications taken within 2 weeks 18. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp) 19. Clinically significant abnormalities in laboratory test results at screening (including hepatic and renal, full blood count, biochemistry and urinalysis) 20. Participation in an investigational drug or device study within 30 days prior to study. 21. Known hypersensitivity to anticholinergic agents 22. Concomitant disease or condition which could interfere with, or for which the treatment of might interfere with, the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. This would include, but is not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease 23. Unwillingness or inability to comply with the study protocol for any other reason. 24. Any clinically significant abnormality on 12-lead ECG |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 30/04/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 15 to 18 subjects |
| Interventions | Single oral administration of PSD506 capsules 5 mg to 40 mg |
| Primary outcome measure(s) | To determine the effects of single oral doses of PSD506 (anti-muscarinic antagonist) on the reduction of unstable urinary bladder detrusor contractions induced by volume provocation testing in patients with hyper-reflexia secondary to spinal injury. |
| Secondary outcome measure(s) |
1. To assess the safety of PSD06 in this population
2. To determine the dose-response of different doses of PSD506 on the reduction of unstable urinary bladder detrusor contractions |
| Sources of funding | Plethora Solutions Ltd (UK) |
| Trial website | |
| Publications | |
| Contact name | Miss Sheryl Caswell |
| Address |
Plethora Solutions
11-13 Macklin Street |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| Tel | +44 (0)207 269 8630 |
| sheryl.caswell@plethorasolutions.co.uk | |
| Sponsor | Plethora Solutions Ltd (UK) |
| Address |
Lupus House
11-13 Macklin Street |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| Tel | +44 (0)207 269 8630 |
| mail@plethorasolutions.co.uk | |
| Sponsor website: | http://www.plethorasolutions.co.uk/index.php |
| Date applied | 15/02/2007 |
| Last edited | 03/05/2011 |
| Date ISRCTN assigned | 20/04/2007 |
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