Prospective, randomized, observer-blind, parallel-group, multi-center trial to assess efficacy and safety of two different dilutions of NT 201 in patients with upper limb spasticity - NT-SPI

• Conditions: Chronic upper limb spasticity caused by diverse etiologies; MedDRA version: 9.0Level: LLTClassification code 10028335

• Registration Number: EUCTR2006-003036-30-DE
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

-Female or male patients =18 years
-Stable upper limb spasticity of diverse etiology: = 6 months after stroke, brain injury or spinal cord injury or multiple sclerosis with no relapse within 3 months prior to screening visit or cerebral palsy
- Focal spasticity with = 2 points on the Ashworth scale in the wrist flexors (incl. clinical pattern of flexed wrist) or wrist (incl. clinical pattern of flexed wrist) and elbow flexors (incl. clinical pattern of flexed elbow)
- Disability Assessment Scale [DAS] score = 2 for principle therapeutic target
- For pre-treated patients only:source documentation of the most recent injection session with botulinum toxin and sufficient therapeutic response for flexed wrist or flexed wrist and elbow
- For pre-treated patients only:Total dose of most recent injection with botulinum toxin must have been not more than of 400 units BOTOX® (1600 units Dysport® or 16.000 units Neurobloc® (type B)) for the affected flexors of wrist or affected flexors of wrist and elbow. For flexor carpi ulnaris, the maximal dose must have been not more than 50 units BOTOX® (200 units Dysport® or 2000 units Neurobloc®), for flexor carpi radialis, the maximal dose must have been not more than 60 units BOTOX® (240 units Dysport® or 2400 units Neurobloc®).
- Negative blood pregnancy test before baseline for females of childbearing potential
- Willingness of the patient to participate as documented by written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Bilateral upper limb paresis/paralysis
- Previous treatment with botulinum toxin of any serotype during the last 4 months prior to screening
- Planned concomitant treatment with botulinum toxin of any serotype and for any body region
- Previous or planned treatment with phenol- or alcohol-injection in the target limb
- Surgical treatment in the target limb for any indication within the 8 weeks prior to screening
- Planned surgery in the target limb
- Hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A
- Change in co-medication with centrally acting muscle relaxants (including benzodiazepines) within the 4 weeks prior to screening and/or co-medication with centrally acting muscle relaxants which dose cannot bekept constant during the trial
- Antispastic medication with peripheral muscle relaxants (including dantrolene) within the 4 weeks prior to screening and during the trial
- Change in antidepressive medication within the 8 weeks prior to screening visit and/or antidepressive medication which dose cannot be kept constant during the trial
- Change in physical or occupational therapy regimens or in any other rehabilitation treatment of spasticity (including splinting) within the 4 weeks prior to screening and/or physical or occupational therapy or any other rehabilitation treatment of spasticity that cannot be kept constant during the trial
- Treatment with intrathecal baclofen within 4 weeks prior to screening
- Other non-authorized concomitant treatments
- Concomitant rheumatic disease in the target limb, which in the opinion of the investigator would affect the therapeutic outcome of treatment with botulinum toxin
- Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch
- Other muscle hypertonia (e.g., rigidity)
- Current alcoholism or other drug abuse/dependence
- Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
- Severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), current malignancy, or anamnestic HIV infection
- Clinically relevant pathological findings in laboratory parameters, indicating active disease of vital organs
- Anticoagulation therapy which requires an INR value of > 2.5
- INR value > 2.5 on injection day
- Severe atrophy of the target limb muscles
- Infection in the area of the planned injection points
- Nursing mothers or women of childbearing potential without reliable means of contraception (reliable contraception is hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g. condom or diaphragm plus spermicidal cream)) and women planning pregnancy during the course of the trial
- Participant in a clinical study within the 4 weeks prior to screening
- Previous randomization in this study
- In the opinion of investigator the patient is unlikely to complete all study visits
- Other contraindications which in the investigator’s opinion preclude participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified