Analysis of the effectiveness of the drug Fampyra® in patients with gait disorder

Phase 1

• Conditions: cerebellar gait disorder, cerebellar ataxia, sensorimotor adaption and ocular motor disorders, postural sway, dysarthria; MedDRA version: 19.0Level: PTClassification code 10008025Term: Cerebellar ataxiaSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-005312-26-DE
• Lead Sponsor: Hospital of the University of Munich, Grosshadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects will only be included in the study if they meet all of the following criteria:
1. Patients male or female, aged between 18 and 80 years
2. Clinical evaluated diagnosis of cerebellar ataxia with at least 2 points in the scale for the assessment and rating of ataxia (SARA)
3. Written informed consent of the subject
4. Subjects, with the ability to follow study instructions and likely to attend and complete all required visits (Compliance).
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

Subjects will not be included in the study if any of the following criteria applies:
1. Weight of 40 kg or less
2. Pregnancy or breast-feeding
3. Concurrend treatment with inhibitors of organic cation transporter 2 (OCT2), e.g. cimetidine
4. Cardiovascular diseases e.g. recent heart attack (within the last 3 months), cardiac arrhythmia (QTc interval > 500 ms, atrial fibrillation, AV block grade = II), unstable angina pectoris (chest tightness due to impaired blood flow to the heart), severe heart failure (NYHA class IV)
5. Recently occurred stroke (within the last 3 months)
6. Epileptic seizure currently or in the past
7. Severe arterial hypertension (grade III according to the guidelines of the German society of cardiology, 2008)
8. Liver insufficiency (e.g. cirrhosis of the liver)
9. Asthma (severity = grade III)
10. Milde or severe renal failure (Creatinine Clearance = 80ml/min)
11. Unadjusted thyroid dysfunction
12. Acute gastric and intestinal ulcer
13. Other acute, serious illness of the subject
14. Subject is unable to understand the nature, scope, significance and consequences of this clinical trial.
15. Subject is unable to comply with the study design
16. Previous participation in this clinical trial or simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this clinical trial

Note to Exclusion Criterion 10. Mild or severe renal failure (Creatinine Clearance = 80ml/min):
If Creatinine Clearance at Screening Visit is > 80ml/min a 24 hour urin sample will be taken (collection start at day of Screening Visit) for re-assessment of Creatinine Clearance.

Study & Design

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