NCT00146809

Double-Blind, Randomised, Two-Armed Study for the Evaluation of Efficacy and Safety of Minocycline for Treatment

Completed Phase 3 Last updated 15 February 2018

What this trial tests

Phase 3 trial testing Minocyline in Multi-System-Atrophy in 60 participants. Completed in 1 December 2005.

Timeline

1 December 2003

1 December 2005

Quick facts

Lead sponsor	German Parkinson Study Group (GPS)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 December 2003
Estimated completion	1 December 2005
Sites	10 locations across Austria, Germany

Drugs / interventions tested

• Minocyline — full drug profile →

Conditions studied

• Multi-System-Atrophy — all drugs for Multi-System-Atrophy →
• Minocycline — all drugs for Minocycline →

Sponsor

German Parkinson Study Group (GPS) — full company profile →

Who can join

Adults 40 to 75, any sex, with Multi-System-Atrophy or Minocycline. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in motor function: Difference between the UMSARS II baseline score and the UMSARS II score 48 weeks after start of therapy

Sponsor's own description

Study Hypothesis:

\- Does a treatment with Minocycline of 2 x daily 2 x 50 mg effect the progression of clinical symptoms and diagnosis in patients with MSA?

Background and Rationale:

* The Parkinson-Syndrome which is characterised by the clinical triad akinesis, rigor and passive tremor, is caused by Parkinson's disease (PD) in about 70 % of the cases (Oertel et al., 2003). However, beside the Parkinson's disease there are several, to some extent rare, so-called atypical Parkinson's syndromes. The two most frequent of these atypical Parkinson-Syndromes are the
* Multi-System-Atrophy (MSA) and the Progressive Supranuclear Palsy (PSP). Due to the often much varying courses and since they are not well known, these diseases are frequently diagnosed late or not diagnosed at all. Nevertheless, an early diagnosis is substantial for further treatment, since the prognosis and therapy of atypical Parkinson Syndromes differ essentially from those of PD. Whereas the neuronal death of cells in PD is restricted essentially to the Substantia nigra, a dominant destruction of neurons in brain stem, Cerebellum and Striatum additionally happens in cases of MSA and PSP.
* Up to now no adequate treatment strategies are at disposal. Initially the giving of L-Dopa can lead to an improvement for \< 10% of the patients only.
* Minocycline is an antibiotic belonging to the group of the Tetracyclines.
* Recently, it could be demonstrated that Minocycline has a neuroprotective impact besides the anti-inflammatory impact.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microglia in neurodegenerative diseases: mechanism and potential therapeutic targets.
   Gao C, Jiang J, Tan Y, Chen S. · · 2023 · cited 998× · PMID 37735487 · DOI 10.1038/s41392-023-01588-0
2. Towards translational therapies for multiple system atrophy.
   Kuzdas-Wood D, Stefanova N, Jellinger KA, Seppi K, et al · · 2014 · cited 31× · PMID 24598411 · DOI 10.1016/j.pneurobio.2014.02.007
3. Multiple system atrophy: an update and emerging directions of biomarkers and clinical trials.
   Liu M, Wang Z, Shang H. · · 2024 · cited 19× · PMID 38483626 · DOI 10.1007/s00415-024-12269-5
4. Current experimental disease-modifying therapeutics for multiple system atrophy.
   Lemos M, Wenning GK, Stefanova N. · · 2021 · cited 13× · PMID 34398313 · DOI 10.1007/s00702-021-02406-z
5. Drug repurposing for disease-modifying effects in multiple system atrophy.
   Jeong SH, Shin JY, Lee PH. · · 2026 · PMID 42010648 · DOI 10.1186/s40035-026-00551-7