GLP-1 analogs for Freidreich's Ataxia treatment.

Active, not recruiting

• Conditions: Friedreich's Ataxia; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-003598-41-BE
• Lead Sponsor: CUB - Hôpital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-08
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male/female patients with FRDA diagnosed by confirmed genetic testing
2. Age 18 years to 70 years
3. Women who are not pregnant or breast feeding, and who do not intend to become pregnant. Women of childbearing potential who must use a reliable contraceptive method and must provide a negative urine pregnancy test at entry into the study
4. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
5. Patient’s 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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current or history of acute or chronic pancreatitis
2. History of gastric or other major bleeding, thyroid neoplasia, hypothyroidism or hyperthyroidism
3. Subjects who have experienced side-effects previously from GLP-1 analogs
4. Use of another investigational product in the past 28 days
5. Current insulin treatment

Study & Design

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