A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-000171-18-FI
• Date of registration: 18/04/2005
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
• Public title: A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/A
• Scientific title: A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/A
• Date of first enrolment: 12/05/2005
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000171-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Finland

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects with relapsing MS or secondary progressive MS with relapses who completed a minimum of 48 weeks of double-blind treatment in study 3066A2-210-WW.
2. Women of childbearing potential must agree to continue to use a medically acceptable form of contraception throughout the study and for 3 months after the last dose of test article is administered.
3. Male subjects must be willing to not father children during the study and for 3 months after the last dose of test article is administered.
4. Subjects must be able and willing to provide signed and dated 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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnancy or lactation.
2. Clinically important abnormalities on the physical examination, vital signs, chest radiograph, or electrocardiogram (ECG) performed at the last visit of the double-blind active phase of study 3066A2-210-WW.
3. Any adverse events or findings observed in study 3066A2-210-WW that, in the opinion of the investigator, would preclude the subject’s entry into the extension study and would require extra medical care to the extent that the study visit schedule is inadequate.
4. Immunomodulatory therapy including interferons, glatiramer acetate (Copaxone), and immunosuppressive therapy including mitoxantrone within 1 week of first test article intake.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple Sclerosis (Relapsing-remitting MS and Secondary progressive MS with relapses)

Intervention(s)

Product Name: Temsirolimus Tablets
Product Code: CCI-779
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Temsirolimus
Current Sponsor code: CCI-779
Other descriptive name: WAY-130799
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Secondary Objective: To obtain preliminary long-term efficacy data in the form of the Expanded Disability Status Scale (EDSS) and the number of relapses occurring during the study.

Primary end point(s): The primary end points are safety data: adverse events, laboratory data, ECG, chest X rays.
Due to the nature of this study, no formal statistical analysis is planned. Evaluation of the data will consist primarily of summary displays (ie, descriptive statistics and graphs) and will be performed on all subjects who will receive at least 1 dose of test article.

Main Objective: To evaluate the safety and tolerability of long-term therapy with 1 dose level of oral CCI-779 (temsirolimus; 8 mg/day) administered to subjects with relapsing-remitting or secondary progressive MS with relapses who completed study 3066A2-210-WW.

Secondary ID(s)

3066A2-214-WW