Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS

Phase 1

• Conditions: Patients with Multiple Sclerosis (MS) or Clinically isolated syndrome suggestive for MS (CIS) are investigated. The main objective is to conserve data about changes in the VIP/PACAP (vasoactive intestinal polypaptide/pituitary adenylate cyclase activating polypeptide) system in stresses patients who start a immunomodulatory treatment with glatiramer acetate (Copaxone).

• Registration Number: EUCTR2009-011088-35-DE
• Lead Sponsor: Philipps-Universität Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-05
• Study Completion: 2015-02-10
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

- informed consent
- age: 18 to 60 years
- diagnosis CIS or relapsing remitting MS
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

- patient younger than 18 or older than 60 years old
- primary or secondary progressive MS
- other autoimmune disease
- pregnancy
- ineffective contraception
- other immunosuppressive or immunomodulatory treatment except corticosteroids in case of a relapse
- intolerance to glatiramer acetate or mannitol
- contraindication against glatiramer acetate
- infectious disease or surgery within four months before study inclusion
- renal insufficiency
- cancer in the medical history
- severe heart disease in the medical history
- participation in another study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: - changes in VIP/PACAP serum concentrations<br>- changes in VIP/PACAP receptor expression on leukocytes;Secondary Objective: - changes of the Th1 and Th2 cytokine profile<br>- changes of the HPA axis<br>- changes in stress handling<br>- changes of the EDSS and MSFC score;Primary end point(s): - changes in VIP/PACAP serum concentration<br>- changes in VIP/PACAP receptor expression on leukocytes