Statin Treatment of Oxysterol Pathology in SPG5: a Randomized Controlled Trial -Proof of Principle

Statin Treatment of Oxysterol Pathology in SPG5: a Randomized Controlled Trial -Proof of Principle - STOP-SPG5

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000978-35-DE

Enrollment

Unknown

Registered

2015-06-19

Start date

2015-10-21

Completion date

Unknown

Last updated

2016-08-16

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

Conditions

SPG5

Interventions

Trade Name: Atorvastatin 10 Product Name: Atorvastatin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Atorvastatin Other descriptive name: ATORVASTATIN HEMICALCIUM 1.5 H2O Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HSP patients with genetically confirmed SPG5 Patient is at least 10 years old Informed consent is given by patients/legal representatives Are the trial subjects under 18? yes Number of subjects for this age range: 2 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Asymptomatic mutation carriers Patient less than 10 years old Treatment with Statins within 3 months before enrolment in studyContraindication to Statin therapy Treatment with fusic acid within 7 days before enrolment in study or ongoing fusic acid medication Treatment with fibrates within 7 days before enrolment in study or ongoing fibrate medication Pregnancy, nursing

Design outcomes

Primary

Measure	Time frame
Main Objective: Change of biomarker 27-hydroxycholesterol (27-OHC) level in serum from baseline to day 56 after treatment with atorvastatin 20/40 mg/d for 8 weeks compared to placebo treatment;Secondary Objective: 27-OHC level in CSF 25-OHC levels in CSF and serum Cholestenoic acid levels in CSF and serum Amyloid?42, Tau and Phospho-Tau (P181) levels in CSF Clinical outcome (Spastic Paraplegia Rating Scale (SPRS), 3 min endurance walk);Primary end point(s): Change of biomarker 27-hydroxycholesterol (27-OHC) level in serum from baseline to day 56 after treatment with atorvastatin 20/40 mg/d for 8 weeks compared to placebo treatment;Timepoint(s) of evaluation of this end point: 56 days after treatment	—

Measure

Time frame

Main Objective: Change of biomarker 27-hydroxycholesterol (27-OHC) level in serum from baseline to day 56 after treatment with atorvastatin 20/40 mg/d for 8 weeks compared to placebo treatment;Secondary Objective: 27-OHC level in CSF 25-OHC levels in CSF and serum Cholestenoic acid levels in CSF and serum Amyloid?42, Tau and Phospho-Tau (P181) levels in CSF Clinical outcome (Spastic Paraplegia Rating Scale (SPRS), 3 min endurance walk);Primary end point(s): Change of biomarker 27-hydroxycholesterol (27-OHC) level in serum from baseline to day 56 after treatment with atorvastatin 20/40 mg/d for 8 weeks compared to placebo treatment;Timepoint(s) of evaluation of this end point: 56 days after treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 27-OHC level in CSF 25-OHC levels in CSF and serum Cholestenoic acid levels in CSF and serum Amyloid?42, Tau and Phospho-Tau (P181) levels in CSF Clinical outcome (Spastic Paraplegia Rating Scale (SPRS), 3 min endurance walk);Timepoint(s) of evaluation of this end point: 56 days after treatment	—

Countries

Germany

Contacts

Public ContactPI, Prof. Dr. L. Schöls

University Hospital Tübingen

ludger.schoels@uni-tuebingen.de0049070712982057

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026