Cervical dystonia, predominantly rotational spasmodic torticollis MedDRA version: 10.0 Level: LLT Classification code 10064124 Term:
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Willingness of the patient to participate as documented by written informed consent - Male or female patient aged = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pre-treatment with botulinum neurotoxin type B (Neurobloc®) at any time prior to study entry - Concomitant treatment with botulinum neurotoxin of any serotype for any other indication (including aesthetic indications) and for any body region during the trial - Traumatic torticollis and tardive torticollis - Previous or planned myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation and/or spinal cord stimulation) - Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A - Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial - Severe swallowing disorder of any origin (Dysphagia Scale score = 3 = severe, with swallowing difficulties and requiring a change in diet) - Predominantly marked limitation on passive range of motion that clinically suggests fixed structures, e.g., cervical contractures or cervical spine syndrome - Present or pre-existing blood coagulation disorders including therapeutic or prophylactic anticoagulation (e.g., heparin, phenprocoumon) - Infection in the area of the planned injection sites or systemic infection presenting a hazard for local injections into the neck muscles - Non-authorized concomitant treatment (see protocol section Prior and Concomitant Therapy) - Current participation in another investigational clinical trial or participation in a clinical trial within the past 3 months - Inability of patient to give informed consent - Nursing mother - Any severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or known HIV infection in medical history - Planned elective surgery under general anesthesia during the trial - Known current alcoholism or other drug abuse/dependence - Being an employee or direct relative of an employee of the involved CRO, the Study Center or Merz Pharmaceuticals For the long-term extension period: - Concomitant treatment with botulinum neurotoxin of any serotype for any other indication (including aesthetic reasons) and for any body region during the trial - Planned myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation and/or spinal cord stimulation) - Severe swallowing disorder of any origin (Dysphagia Scale score ³ 3 = severe, with swallowing difficulties and requiring a change in diet - Predominantly marked limitation on passive range of motion that clinically suggests fixed structures, e.g., cervical contractures or cervical spine syndrome - Present or pre-existing blood coagulation disorder including therapeutic or prophylactic anticoagulation (e.g., heparin, phenprocoumon) - Infection in the area of the planned injection sites or systemic infection presenting a hazard for local injections into the neck muscles - Non-authorized concomitant treatment (see protocol section Prior and Concomitant Therapy9.4.7) - Nursing mother - Any severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection - Planned elective surgery under general anesthesia during the trial - Known current alcoholism or other drug abuse/dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to confirm the safety and efficacy of NT 201 after one injection session in the treatment of patients with cervical dystonia. ;Secondary Objective: As secondary objectives the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions will be determined. In addition, the usefulness of a patient diary for achievement of optimal treatment during this period in clinical practice will be investigated. As part of the safety evaluations during the Main Period and the Extension Period, the incidence of adverse events (AEs) and the formation of antibodies will be investigated. ;Primary end point(s): TWSTRS – total score : Change from baseline to week 4 after initial injection session | — |
Countries
Germany
Outcome results
None listed