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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011088-35-DE
Enrollment
30
Registered
2010-02-05
Start date
2010-03-24
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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).

Interventions

Trade Name: Copaxone Product Name: copaxone Product Code: 52069.00.01 Pharmaceutical Form: Solution for injection INN or Proposed INN: glatiramer acetate CAS Number: 147245-92-9 Concentration unit: mg

Sponsors

Philipps-Universität Marburg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026