Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01357980
First received: May 17, 2011
Last updated: August 21, 2014
Last verified: August 2014
  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:


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
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

Locations
Czech Republic
THOMAYER Faculty Hospital
Praha, Czech Republic
Faculty Hospital Motol
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

No publications provided

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:
Multiple Sclerosis
Hyperkinesis
Spinal Cord Injuries
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Central Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Dyskinesias
Immune System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014