Text Size

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: March 31, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Mean change from baseline in daily incontinence episode frequency [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urodynamic examination [ Time Frame: Screening visit, day 14, 42 and 84 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment score of treatment response [ Time Frame: Day 14, 42 and 84 ] [ Designated as safety issue: No ]
  • Quality of life total summary score [ Time Frame: Day 1, 14, 42 and 84 ] [ Designated as safety issue: No ]
  • Pain visual analogue scale (VAS) score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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 using different administration regimen, intra detrusor injection on day 1 (single dose)
Placebo Comparator: Placebo (15 injection sites) Drug: Placebo
Intra detrusor injection
Experimental: Dysport 750 U (30 injection sites) Drug: Botulinum type A toxin (Dysport®)
750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
Placebo Comparator: Placebo (30 injection sites) Drug: Placebo
Intra detrusor injection

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary incontinence as a result of Neurogenic Detrusor Overactivity due to documented spinal cord injury (SCI) or multiple sclerosis (MS)
  • Have a documented SCI or MS
  • Have a minimum average of 2 incontinences episodes per day

Exclusion Criteria:

  • Greater than 3 L diuresis per day
  • History of Neurogenic detrusor overactivity due to an aetiology other than SCI or MS
  Contacts and Locations
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
Hopital Tenon
Paris, France
Groupe Hospitalier La Pitié Salpetriere
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
Last Updated: March 31, 2013
Health Authority: France: L’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
Sclerosis
Spinal Cord Injuries
Hyperkinesis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Spinal Cord Diseases
 Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013