NCT05855577

-Clinical Efficacy of Pharmacological Treatments Targeting Energy Metabolism, Evaluated by Gait Analysis, on Motor Function in Parkinson's Disease Patients

Status unknown Phase 4 Last updated 21 September 2023

What this trial tests

Phase 4 trial testing Terazosin in Parkinson Disease in 50 participants. Status unknown.

Timeline

1 December 2023

Primary endpoint
1 May 2026

1 May 2026

Quick facts

Lead sponsor	I.R.C.C.S. Fondazione Santa Lucia
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 December 2023
Primary completion	1 May 2026
Estimated completion	1 May 2026

Drugs / interventions tested

• Terazosin (TERAZOSIN) — full drug profile →

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Gait Analysis — all drugs for Gait Analysis →
• Therapy, Directly Observed — all drugs for Therapy, Directly Observed →
• Metabolic Disease — all drugs for Metabolic Disease →

Sponsor

I.R.C.C.S. Fondazione Santa Lucia — full company profile →

Who can join

40 and older, any sex, with Parkinson Disease or Gait Analysis. 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.

• Clinical evaluation, Gait Analysis and Metabolic variables efficacy of therapy
  Time frame: 2year
  MD UPDRs : Four Parts: II questionary by Parkinsonian or care-given, III-IV: Motor Part and Complication by neurologist , Each item rate from 0: no sign to 4: max sign PDQ39 questionary performed by Parkinsonian each item rate from 0: never, to 5:always. Gait Analysis following spatio-temporal parameters will be taken in to account: Right and Left Step Length, Stride time% Stance Swing , Double su

Sponsor's own description

Consistent evidence suggests that mitochondrial dysfunction plays a crucial role in Parkinson¿s disease pathogenesis.

Inhibition of complex I of the mitochondrial electron transport chain is sufficient to reproduce biochemical and pathological features of Parkinson¿s Disease in animal models (PD). Alterations of mitochondrial energy metabolism may intervene in PD pathogenesis by inducing inflammation, generation of reactive oxygen species (ROS), and neurodegeneration. The Nuclear factor erythroid 2-related factor 2 (Nrf2) is a regulator both of mitochondrial function and biogenesis, and of cellular resistance to oxidative stress, and may represent a novel target of PD disease-modifying therapies.

The aims of the present study are to validate indicators of energy metabolism as biomarkers in PD patients and to evaluate the efficacy of drugs and natural food supplements acting on the Nrf2 pathway in improving motor impairment and Gait in PD patients.

Publications & conference data

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

1. Role of mitochondria in physiological activities, diseases, and therapy.
   Wang L, Zhou X, Lu T. · · 2025 · cited 23× · PMID 40536597 · DOI 10.1186/s43556-025-00284-5
2. Pharmacotherapy for Disease Modification in Early Parkinson's Disease: How Early Should We Be?
   Mahlknecht P, Poewe W. · · 2024 · cited 6× · PMID 38427503 · DOI 10.3233/jpd-230354
3. Clinical Trial Highlights: Modulators of Mitochondrial Function.
   Capriglia F, Burgess T, Bandmann O, Mortiboys H. · · 2023 · cited 1× · PMID 37694310 · DOI 10.3233/jpd-239003
4. Nanotherapeutic Interventions for Parkinson's Disease: Modulating Pathogenic Mechanisms and Overcoming Therapeutic Obstacles.
   Yin X, Wang C, Lin W, Huang S, et al · · 2026 · PMID 41907367 · DOI 10.2147/ijn.s570452
5. Disease-Modifying Trials in Treated Parkinson's Disease: "Stable Treated" Does Not Equate with Biological Stability.
   Mouradian MM, Stoessl AJ, Lang AE. · · 2025 · PMID 40635563 · DOI 10.1002/mds.30259