Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
This study has been completed.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01357980
First received: May 17, 2011
Last updated: August 21, 2014
Last verified: August 2014
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Purpose
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Detrusor Muscle Hyperactivity |
Drug: Botulinum type A toxin (Dysport®) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
Drug Information available for:
OnabotulinumtoxinA
U.S. FDA Resources
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Daily Incontinence Episode Frequency (IEF) [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urodynamics: Maximum Cystometric Capacity [ Time Frame: Baseline, Days 14, 42 and 84 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 47 |
| Study Start Date: | May 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dysport 750 U (15 injection sites) |
Drug: Botulinum type A toxin (Dysport®)
750 U intra detrusor injection on Day 1 (single dose)
|
| Placebo Comparator: Placebo (15 injection sites) |
Drug: Placebo
Intra detrusor injection on Day 1 (single dose)
|
| Experimental: Dysport 750 U (30 injection sites) |
Drug: Botulinum type A toxin (Dysport®)
750 U intra detrusor injection on Day 1 (single dose)
|
| Placebo Comparator: Placebo (30 injection sites) |
Drug: Placebo
Intra detrusor injection on Day 1 (single dose)
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357980
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357980
Locations
| Czech Republic | |
| Faculty Hospital Motol | |
| Praha, Czech Republic | |
| THOMAYER Faculty Hospital | |
| Praha, Czech Republic | |
| France | |
| Hopital Raymond Poincaré | |
| Garches, France | |
| Hopital HURIET | |
| Lille, France | |
| Hôpital Lyon Sud -Hospices Civils de Lyon | |
| Lyon, France | |
| Hopital de la conception | |
| Marseille, France | |
| CHU Hotel Dieu | |
| Nantes, France | |
| Groupe Hospitalier La Pitié Salpetriere | |
| Paris, France | |
| Hopital Tenon | |
| Paris, France | |
| CMRRF Kerpape | |
| Ploemeur, France | |
| CHU Rouen - Hopital Charles Nicolle | |
| Rouen, France | |
| Nouvel Hopital civil de Strasbourg | |
| Strasbourg, France | |
| CHU Toulouse - Hopital Rangueil | |
| Toulouse, France | |
| Germany | |
| Universitätsklinik Kiel | |
| Kiel, Germany | |
| Städtisches Klinikum Neunkirchen | |
| Neunkirchen, Germany | |
| Italy | |
| Ospedale Careggi | |
| Firenze, Italy | |
| Poland | |
| NZOZ Centrum Medyczne Mazovia | |
| Warszawa, Poland | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Study Director | Ipsen |
More Information
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT01357980 History of Changes |
| Other Study ID Numbers: | Y-52-52120-155 |
| Study First Received: | May 17, 2011 |
| Results First Received: | March 27, 2014 |
| Last Updated: | August 21, 2014 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Austria: Agency for Health and Food Safety Poland: The Central Register of Clinical Trials Czech Republic: State Institute for Drug Control Italy: The Italian Medicines Agency |
Keywords provided by Ipsen:
|
Detrusor Muscle Overactivity |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis Spinal Cord Injuries Pathologic Processes 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 AbobotulinumtoxinA Botulinum Toxins, Type A OnabotulinumtoxinA IncobotulinumtoxinA 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 |
ClinicalTrials.gov processed this record on September 23, 2016