Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01357980 |
|
Recruitment Status :
Completed
First Posted : May 23, 2011
Results First Posted : September 1, 2014
Last Update Posted : September 27, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Detrusor Muscle Hyperactivity | Biological: Botulinum toxin type A Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 47 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis. |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | March 2013 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dysport 750 U (15 injection sites) |
Biological: Botulinum toxin type A
750 U intra detrusor injection on Day 1 (single dose)
Other Name: AbobotulinumtoxinA (Dysport®) |
| Placebo Comparator: Placebo (15 injection sites) |
Drug: Placebo
Intra detrusor injection on Day 1 (single dose) |
| Experimental: Dysport 750 U (30 injection sites) |
Biological: Botulinum toxin type A
750 U intra detrusor injection on Day 1 (single dose)
Other Name: AbobotulinumtoxinA (Dysport®) |
| Placebo Comparator: Placebo (30 injection sites) |
Drug: Placebo
Intra detrusor injection on Day 1 (single dose) |
- Daily Incontinence Episode Frequency (IEF) [ Time Frame: Baseline and Day 84 ]
- Urodynamics: Maximum Cystometric Capacity [ Time Frame: Baseline, Days 14, 42 and 84 ]Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.
- Urodynamics:Maximum Detrusor Pressure [ Time Frame: Baseline, Days 14, 42 and 84 ]Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.
- Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 14 ]The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
- Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 42 ]The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
- Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 84 ]The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
- Quality of Life (QoL) Total Summary Score [ Time Frame: Baseline, 14, 42 and 84 ]
Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score.
The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0="Not at all" to 4="Extremely" for the first 6 items, from 0="Never" to 4="Always" for item 7 and from 0="Always" to 4="Never" for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated.
Total score has been calculated as the mean of all the items completed among the 8 items.
Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL.
- Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection [ Time Frame: Baseline ]Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
- Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure [ Time Frame: Baseline ]Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
- Inadequate response or refractory to anticholinergic medication
- Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
- Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit
Exclusion Criteria:
- Significant Baseline renal and/or urinary tract pathology
- Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357980
Show 17 study locations
| Study Director: | Ipsen Study Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT01357980 |
| Other Study ID Numbers: |
Y-52-52120-155 2010-023210-31 ( EudraCT Number ) |
| First Posted: | May 23, 2011 Key Record Dates |
| Results First Posted: | September 1, 2014 |
| Last Update Posted: | September 27, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board. |
| Time Frame: | Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later. |
| Access Criteria: | Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/). |
| URL: | https://vivli.org/members/ourmembers/ |
|
Detrusor Muscle Overactivity |
|
Multiple Sclerosis Spinal Cord Injuries Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |