Spasticity of the Upper and Lower Limb Due to Cerebral Causes Clinical Trial
Official title:
Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side Due to Cerebral Causes
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
| Status | Completed |
| Enrollment | 155 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Upper and lower limb spasticity of the same body side due to cerebral causes - Time since event leading to spasticity in the target body side greater than 12 weeks - Need for 800 units Botulinum toxin type A Exclusion Criteria: - Body weight below 50kg - Fixed contractures of the target joint - Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A - Infection at the injection site |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Merz Investigational Site # 001203 | Calgary, AB | |
| Canada | Merz Investigational site #001195 | Edmonton, AB | |
| France | Merz Investigational Site # 033018 | Garches | |
| France | Merz Investigational Site #033049 | Montpellier | |
| France | Merz Investigational Site # 033050 | Nimes | |
| Germany | Merz Investigational Site #049191 | Aachen | |
| Germany | Merz Investigational Site #049297 | Bad Aibling | |
| Germany | Merz Investigational Site #049022 | Beelitz-Heilstätten | |
| Germany | Merz Investigational Site #049298 | Berlin | |
| Germany | Merz Investigational Site # 049153 | Gießen | |
| Germany | Merz Investigational Site #049295 | Göttingen | |
| Germany | Merz Investigational Site #049300 | Nümbrecht | |
| Germany | Merz Investigational Site #049296 | Tübingen | |
| Italy | Merz Investigational Site # 039005 | Lecco | |
| Italy | Merz Investigational Site # 039010 | Milano | |
| Italy | Merz Investigational Site # 039015 | Milano | |
| Italy | Merz Investigational Site # 039017 | Novara | |
| Italy | Merz Investigational Site #039013 | Passignano sul Trasimeno | |
| Italy | Merz Investigational Site #039016 | San Giovanni Rotondo | |
| Italy | Merz Investigational Site #039014 | Verona | |
| Norway | Merz Investigational Site #047001 | Bergen | |
| Portugal | Merz Investigational Site # 351001 | Lisboa | |
| Portugal | Merz Investigational Site # 351003 | Lisbon | |
| Spain | Merz Investigational Site #034007 | Madrid | |
| Spain | Merz Investigational Site #034025 | Malaga | |
| Spain | Merz Investigational Site #034022 | Manresa | |
| Spain | Merz Investigational Site #034024 | Santander | |
| United States | Merz Investigational Site #001238 | Charlotte | North Carolina |
| United States | Merz Investigational Site # 001232 | Cleveland | Ohio |
| United States | Merz Investigational Site # 001197 | Doral | Florida |
| United States | Merz Investigational Site # 001235 | Indianapolis | Indiana |
| United States | Merz Investigational Site #001237 | Milwaukee | Wisconsin |
| United States | Merz Investigational Site # 001191 | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Merz Pharmaceuticals GmbH |
United States, Canada, France, Germany, Italy, Norway, Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurence of treatment-emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by injection cycle | Week 12-16 | Yes | |
| Primary | Occurence of treatment-emergent AEs, AESIs, and SAEs related to the administration of study medication by injection cycle | Week 12-16 | Yes | |
| Primary | Investigator's global assessment of tolerability using a 4-point Likert scale at end of injection cycle visits | A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. | Week 12-16 | Yes |
| Primary | Occurence of treatment-emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by injection cycle | Week 24-32 | Yes | |
| Primary | Occurence of treatment-emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by injection cycle | Week 36-48 | Yes | |
| Primary | Occurence of treatment-emergent AEs, AESIs, and SAEs related to the administration of study medication by injection cycle | Week 24-32 | Yes | |
| Primary | Occurence of treatment-emergent AEs, AESIs, and SAEs related to the administration of study medication by injection cycle | Week 36-48 | Yes | |
| Primary | Investigator's global assessment of tolerability using a 4-point Likert scale at end of injection cycle visits | A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. | Week 24-32 | Yes |
| Primary | Investigator's global assessment of tolerability using a 4-point Likert scale at end of injection cycle visits | A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. | Week 36-48 | Yes |
| Secondary | Ashworth Scale (AS) of the target joint selected at study baseline visit | The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | From baseline up to week 48 | No |
| Secondary | AS of every joint affected by clinical patterns of spasticity and treated at least once, of the same body side as the selected target joint. | The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | From baseline up to week 48 | No |
| Secondary | Resistance to passive movement scale (REPAS) | The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). | From baseline up to week 48 | No |
| Secondary | Functional ambulation classification (FAC) scale | The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. |
From baseline up to week 48 | No |
| Secondary | Global attainment scale (GAS) for upper and lower limb, respectively | GAS measures the extent to which a subject's individual goals are achieved in the course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Each goal is rated on a 5-point scale, with degree of attainment captured for each goal area: -2 = a lot less than expected; -1 = a little less than expected; 0 = expected level of achievement; +1 = a little better than expected; +2 = a lot better than expected. The GAS score at injection cycle baseline is always set as -1. | Up to week 48 | No |
| Secondary | Disability Assessment Scale (DAS) in a selected principal therapeutic target domain affecting the upper limb | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per injection cycle. | From baseline up to week 48 | No |
| Secondary | EuroQoL 5-dimensions questionnaire (EQ-5D) | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. | From baseline up to week 48 | No |
| Secondary | Global assessment of efficacy | The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. | Up to week 48 | No |