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

Phase 4

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00004368
• Lead Sponsor: Philipps-Universität Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-12-20
• Study Start: 2013-01-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

signed Informed Consent
- diagnosis of either relapsing remitting Multiple Sclerosis (RR-MS) or Clinically isolted syndrome (CIS)
- therapy naive

Exclusion Criteria

- diagnosis of primary or secondary progressive Multiple Sclerosis (PP-MS or SP-MS)
- diagnosis of any other autoimmune disorder
- actual or past treatment with Interferons, Glatirameracetate, Azathioprine, intravenous immunglobulin (IVIG), Natalizumab, Mitoxantrone, Cyclophosphamide, non-steroidal Antirheumatics or any other immunomodulating or immunosuppressive substances other than corticosteroids as relapse treatment
- positive pregnancy-testing in female patients
- inadequate contraception
- Hypersensitivity to Glatirameracetate or Mannitol
- othe contraindications against Copaxone
- participation in any other clinical trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relative changes in VIP/PACAP-concentrations in the serum and of VIP/PACAP-receptor expression on leucocytes for analysis of stress induced (dys) funcuions during a time of 8 month at screening, week 3, week 5, month 4 and month 8 (arm A) or at screening, week 3, month 4, month 4+2 weeks and month 8 (arm B)

Secondary Outcome Measures

Name	Time	Method
1) changes of hypothalamus-hypophysis-adrenal cortex-achsis (Dex-CRH-test) at week 3, month 4 and month 8 (detection of ACTH and cortisol)<br>2) changes in dealing with stress (questionaires) at all visites<br>3) changes of Th1- and Th2-cytocin-production at all visits<br>4) changes of grade of disabilities via EDSS- and MSFC scores at all visits (EDSS-Kurtzke scores and MSFC scores)<br><br>